Ergonomic iv systems and methods

ABSTRACT

An IV catheter system may have a catheter component with a catheter hub, a cannula extending distally from the catheter hub, and a push feature protruding outwardly from the catheter hub. The IV catheter system may also have a needle component with a needle hub, a needle extending distally from the needle hub along an axis, and a grip extending from the needle hub, generally parallel to the axis, with a pull feature. In the insertion configuration, the needle may be positioned within the cannula and the distal end of the needle hub may be seated in a needle port of the catheter hub. In the fluid delivery configuration, the needle may be positioned outside the catheter hub. The push and pull features may be positioned to facilitate manipulation with a single hand to move the IV catheter system from an insertion configuration to a fluid delivery configuration.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 62/247,596, which was filed on Oct. 28, 2015, U.S.Provisional Patent Application No. 62/296,383, which was filed on Feb.17, 2016, U.S. Provisional Patent Application No. 62/247,599, which wasfiled Oct. 28, 2015, U.S. Provisional Patent Application No. 62/247,617,which was filed on Oct. 28, 2015, U.S. Provisional Patent ApplicationSer. No. 62/247,607, which was filed Oct. 28, 2015, U.S. ProvisionalPatent Application Ser. No. 62/247,621, which was filed Oct. 28, 2015,U.S. Provisional Patent Application Ser. No. 62/247,624, which was filedOct. 28, 2015, U.S. Provisional Application No. 62/247,626, which wasfiled on Oct. 28, 2015, and U.S. Provisional Application No. 62/296,385,which was filed on Feb. 17, 2016, each of which is incorporated hereinby reference in their entirety.

BACKGROUND

The present invention is generally directed to systems and methods forintravenous (“IV”) delivery, by which fluids can be administereddirectly to the vascular system of a patient. More particularly, thepresent invention is directed to IV catheter systems and methods thatfacilitate insertion into the patient and/or motion from an insertionconfiguration to a fluid delivery configuration in which fluid can bedelivered to the patient through the IV catheter system. An IV cathetersystem according to the invention is used broadly herein to describecomponents used to deliver the fluid to the patient, for use inarterial, intravenous, intravascular, peritoneal, and/or non-vascularadministration of fluid. Of course, one of skill in the art may use anIV catheter system to administer fluids to other locations within apatient's body.

Known IV catheter systems and methods have a number of deficiencies.Many such systems require the clinician to use two hands to position theIV catheter system and/or insert the needle into the fluid deliverylocation on the patient (for example, the vein into which fluid is to bedelivered). Further, many such systems require the clinician to use twohands to move the IV catheter system from the insertion configuration toa fluid delivery configuration, in which the needle is removed from thecannula to permit fluid to be delivered to the vein through the cannula.Thus, the clinician is required to stabilize the patient's arm or otherbody part having the fluid delivery location prior to insertion of theIV catheter system. As a result, extra time is required for theclinician to initiate transfusion. Further, the clinician is unable toperform any other task, such as stabilizing or reassuring the patient,during insertion and/or motion to the fluid delivery configuration.

Accordingly, there is a need for IV catheter systems and methods thatfacilitate IV catheter system placement, insertion, and/or preparationfor fluid delivery. There is a further need for such IV catheter systemsthat are inexpensive, easy to manufacture, and versatile.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention are generally directed to an IVcatheter system with enhanced ergonomics. In some embodiments, the IVcatheter system may be inserted and moved to the fluid deliveryconfiguration with only one hand. The IV catheter system may have acatheter component with a catheter component and a needle component. Thecatheter component may have a catheter hub with a catheter hub distalend and a catheter hub proximal end. The catheter hub may be shaped todefine a chamber extending between the catheter hub distal end and thecatheter hub proximal end, and a needle port at the catheter hubproximal end that provides access to the chamber. The catheter componentmay also have a cannula extending distally from the catheter hub distalend, and a push feature protruding outwardly from the catheter hub. Theneedle component may have a needle hub with a needle hub distal end anda needle hub proximal end, a needle extending distally from the needlehub distal end along an axis, and a grip extending from the needle hub,generally parallel to the axis. The grip may have a pull feature. In theinsertion configuration, the needle may be positioned within the cannulaand the needle hub distal end may be seated in the needle port. In thefluid delivery configuration, the needle may be positioned outside thecatheter hub. The push feature may be positioned to receive firstcontact from a first digit of a hand of a user to urge the catheter hubdistally. Further, the pull feature may be positioned to receive secondcontact from a second digit of the hand simultaneously with receipt ofthe first contact such that the first and second contacts cooperate tourge the IV catheter system to move from the insertion configuration tothe fluid delivery configuration.

The catheter hub may have a catheter hub intermediate portion betweenthe catheter hub proximal end and the catheter hub distal end. Thecatheter component may further have an extension tubing junctionextending outwardly from the catheter hub intermediate portion toconnect the catheter hub to extension tubing. The push feature may havea push surface extending between the catheter hub intermediate portionand the extension tubing junction. The push surface may be orientedsubstantially perpendicular to the axis.

The grip may have a recess shaped to receive the extension tubingjunction in the insertion configuration. Moving the IV catheter systemfrom the insertion configuration to the fluid delivery configuration mayinclude rotating the needle component relative to the catheter componentabout the axis to withdraw the extension tubing junction from therecess.

The catheter component may further have a septum within the chamber,through which the needle passes in the insertion configuration. Theseptum may be configured to provide a sufficiently low resistance towithdrawal of the needle through the septum to enable the hand, alone,to move the IV catheter system from the insertion configuration to thefluid delivery configuration.

The catheter component may further have a securement platform with afirst wing extending from the catheter hub, generally parallel to theaxis. In the fluid delivery configuration, the first wing may rest onskin of a patient receiving fluid through the IV catheter system.

The securement platform may further have a second wing extending fromthe catheter hub, generally coplanar with the first wing. In the fluiddelivery configuration, the second wing may also rest on the skin.

In the insertion configuration, the first wing and the grip may begenerally parallel to each other and may be positioned in abuttingrelation to each other. During motion of the IV catheter system from theinsertion configuration to the fluid delivery configuration, the gripmay slide along the first wing.

At least one of the first wing and the grip may have one or morealignment features. The alignment features may cause the first wing andthe grip to remain positioned in abutting relation to each other duringmotion of the IV catheter system from the insertion configuration towardthe fluid delivery configuration.

At least one of the first wing and the grip may have one or more lockingfeatures. The locking features may cause the IV catheter system toremain in the insertion configuration until the first contact and thesecond contact cooperate to provide a disengagement force sufficient tounlock the one or more locking features.

The pull feature may be a leading edge of the grip. The leading edge maybe shaped and sized to comfortably receive the second contact.

According to one exemplary method for preparing an IV catheter system todeliver fluid to a patient, the IV catheter system may again have aninsertion configuration and a fluid delivery configuration. The methodmay include positioning the IV catheter system proximate a fluiddelivery location of a patient. The IV catheter system may have acatheter component and a needle component. The catheter component mayhave a catheter hub that has a catheter hub distal end and a catheterhub proximal end. The catheter hub may be shaped to define a chamberextending between the catheter hub distal end and the catheter hubproximal end, and a needle port at the catheter hub proximal end thatprovides access to the chamber. The catheter component may also have acannula extending distally from the catheter hub distal end, and a pushfeature protruding outwardly from the catheter hub. The needle componentmay have a needle hub that has a needle hub distal end and a needle hubproximal end. The needle component may also have a needle extendingdistally from the needle hub distal end along an axis, and a gripextending generally parallel to the axis, the grip comprising a pullfeature. The method may also include, with the IV catheter system in theinsertion configuration, in which the needle is positioned within thecannula and the needle hub distal end is seated in the needle port,using a single hand to insert the needle and the cannula into the fluiddelivery location. Further, the method may include, with the needle andcannula in the fluid delivery location, using the single hand to pushthe push feature while pulling the pull feature to urge the IV cathetersystem to move from the insertion configuration to the fluid deliveryconfiguration, in which the needle is positioned outside the catheterhub.

The catheter hub may have a catheter hub intermediate portion betweenthe catheter hub proximal end and the catheter hub distal end. Thecatheter component may further have an extension tubing junctionextending outwardly from the catheter hub intermediate portion toconnect the catheter hub to extension tubing. The push feature may be apush surface extending between the catheter hub intermediate portion andthe extension tubing junction. The push surface may be orientedsubstantially perpendicular to the axis. Pushing the push feature mayinclude pressing on the push surface.

The catheter component may further have a securement platform with afirst wing extending from the catheter hub, generally parallel to theaxis. Urging the IV catheter system to move from the insertionconfiguration to the fluid delivery configuration may includepositioning the first wing to rest on skin of the patient.

In the insertion configuration, the first wing and the grip may begenerally parallel to each other and may be positioned in abuttingrelation to each other. Urging the IV catheter system to move from theinsertion configuration to the fluid delivery configuration may includecausing the grip to slide along the first wing.

At least one of the first wing and the grip may have one or morealignment features. Urging the IV catheter system to move from theinsertion configuration to the fluid delivery configuration may include,with the one or more alignment features, causing the first wing and thegrip to remain positioned in abutting relation to each other duringmotion of the IV catheter system from the insertion configuration towardthe fluid delivery configuration.

At least one of the first wing and the grip may have one or more lockingfeatures. Urging the IV catheter system to move from the insertionconfiguration to the fluid delivery configuration may include providinga disengagement force sufficient to unlock the one or more lockingfeatures.

The pull feature may be a leading edge of the grip. Pulling the pullfeature may include pulling on the leading edge with the single hand.

In some embodiments, an IV catheter system may have an insertionconfiguration and a fluid delivery configuration. The IV catheter systemmay have a catheter component and a needle component. The cathetercomponent may have a catheter hub with a catheter hub distal end, acatheter hub proximal end, and a catheter hub intermediate portionbetween the catheter hub proximal end and the catheter hub distal end.The catheter hub may be shaped to define a chamber extending between thecatheter hub distal end and the catheter hub proximal end, and a needleport at the catheter hub proximal end that provides access to thechamber. The catheter component may also have a cannula extendingdistally from the catheter hub distal end, an extension tubing junctionextending outwardly from the catheter hub intermediate portion toconnect the catheter hub to extension tubing, a septum within thechamber, and a push feature protruding outwardly from the catheter hub.The needle component may have a needle hub with a needle hub distal endand a needle hub proximal end, a needle extending distally from theneedle hub distal end along an axis, and a grip extending generallyparallel to the axis. The grip may have a pull feature defined by aleading edge of the grip. In the insertion configuration, the needle maybe positioned within the cannula, the needle may pass through theseptum, and the needle hub distal end may be seated in the needle port.In the fluid delivery configuration, the needle may be positionedoutside the catheter hub. The push feature may be positioned to receivefirst contact from a first digit of a hand of a user to urge thecatheter hub distally. Further, the pull feature may be positioned toreceive second contact from a second digit of the hand simultaneouslywith receipt of the first contact such that the first and secondcontacts cooperate to urge the IV catheter system to move from theinsertion configuration to the fluid delivery configuration. The leadingedge may be shaped and sized to comfortably receive the second contact.The septum may be configured to provide a sufficiently low resistance towithdrawal of the needle through the septum to enable the hand, alone,to move the IV catheter system from the insertion configuration to thefluid delivery configuration.

The push feature may have a push surface extending between the catheterhub intermediate portion and the extension tubing junction. The pushsurface may be oriented substantially perpendicular to the axis.

The catheter component may further have a securement platform with afirst wing extending from the catheter hub, generally parallel to theaxis such that, in the fluid delivery configuration, the first wingrests on skin of a patient receiving fluid through the IV cathetersystem. Further, the catheter component may have a second wing extendingfrom the catheter hub, generally coplanar with the first wing such that,in the fluid delivery configuration, the second wing also rests on theskin. In the insertion configuration, the first wing and the grip may begenerally parallel to each other and may be positioned in abuttingrelation to each other. During motion of the IV catheter system from theinsertion configuration to the fluid delivery configuration, the gripmay slide along the first wing.

In a first implementation of the invention, an IV catheter system isprovided comprising an insertion configuration and a fluid deliveryconfiguration, the IV catheter system comprising a catheter componentcomprising: a catheter hub comprising a catheter hub distal end and acatheter hub proximal end, wherein the catheter hub is shaped to definea chamber extending between the catheter hub distal end and the catheterhub proximal end, and a needle port at the catheter hub proximal endthat provides access to the chamber; a cannula extending distally fromthe catheter hub distal end; and a push feature protruding outwardlyfrom the catheter hub. The IV catheter system further comprises a needlecomponent comprising: a needle hub comprising a needle hub distal endand a needle hub proximal end; a needle extending distally from theneedle hub distal end along an axis; and a grip extending from theneedle hub, generally parallel to the axis, the grip comprising a pullfeature, wherein, in the insertion configuration, the needle ispositioned within the cannula and the needle hub distal end is seated inthe needle port, and wherein, in the fluid delivery configuration, theneedle is positioned outside the catheter hub, and wherein the pushfeature is positioned to receive first contact from a first digit of ahand of a user to urge the catheter hub distally and the pull feature ispositioned to receive second contact from a second digit of the handsimultaneously with receipt of the first contact such that the first andsecond contacts cooperate to urge the IV catheter system to move fromthe insertion configuration to the fluid delivery configuration.

In some instances, the catheter hub of the IV catheter system furthercomprises a catheter hub intermediate portion between the catheter hubproximal end and the catheter hub distal end, wherein the cathetercomponent further comprises an extension tubing junction extendingoutwardly from the catheter hub intermediate portion to connect thecatheter hub to extension tubing, wherein the push feature comprises apush surface extending between the catheter hub intermediate portion andthe extension tubing junction, wherein the push surface is orientedsubstantially perpendicular to the axis.

In some instances, the grip of the IV catheter system further comprisesa recess shaped to receive the extension tubing junction in theinsertion configuration, wherein moving the IV catheter system from theinsertion configuration to the fluid delivery configuration comprisesrotating the needle component relative to the catheter component aboutthe axis to withdraw the extension tubing junction from the recess.

In some instances, the catheter component of the IV catheter systemfurther comprises a septum within the chamber, through which the needlepasses in the insertion configuration, wherein the septum is configuredto provide a sufficiently low resistance to withdrawal of the needlethrough the septum to enable the hand, alone, to move the IV cathetersystem from the insertion configuration to the fluid deliveryconfiguration. In some instances, the catheter component furthercomprises a securement platform comprising a first wing extending fromthe catheter hub, generally parallel to the axis such that, in the fluiddelivery configuration, the first wing rests on skin of a patientreceiving fluid through the IV catheter system.

In some instances, the securement platform of the IV catheter systemfurther comprises a second wing extending from the catheter hub,generally coplanar with the first wing such that, in the fluid deliveryconfiguration, the second wing also rests on the skin.

In some instances, the first wing and the grip are generally parallel toeach other and are positioned in abutting relation to each other in theinsertion configuration of the IV catheter system, wherein, duringmotion of the IV catheter system from the insertion configuration to thefluid delivery configuration, the grip slides along the first wing.

In some instances, at least one of the first wing and the grip of the IVcatheter system comprises one or more alignment features that cause thefirst wing and the grip to remain positioned in abutting relation toeach other during motion of the IV catheter system from the insertionconfiguration toward the fluid delivery configuration. In someinstances, at least one of the first wing and the grip comprises one ormore locking features that cause the IV catheter system to remain in theinsertion configuration until the first contact and the second contactcooperate to provide a disengagement force sufficient to unlock the oneor more locking features.

In some instances, the pull feature of the IV catheter system comprisesa leading edge of the grip, wherein the leading edge is shaped and sizedto comfortably receive the second contact.

In a second implementation of the invention, a method is provided forpreparing an IV catheter system to deliver fluid to a patient, the IVcatheter system comprising an insertion configuration and a fluiddelivery configuration, and the method comprising: 1) positioning the IVcatheter system proximate a fluid delivery location of a patient,wherein the IV catheter system comprises a catheter componentcomprising: a catheter hub comprising a catheter hub distal end and acatheter hub proximal end, wherein the catheter hub is shaped to definea chamber extending between the catheter hub distal end and the catheterhub proximal end, and a needle port at the catheter hub proximal endthat provides access to the chamber; a cannula extending distally fromthe catheter hub distal end; and a push feature protruding outwardlyfrom the catheter hub; and a needle component comprising: a needle hubcomprising a needle hub distal end and a needle hub proximal end; aneedle extending distally from the needle hub distal end along an axis;and a grip extending from the needle hub, generally parallel to theaxis, the grip comprising a pull feature; 2) with the IV catheter systemin the insertion configuration, in which the needle is positioned withinthe cannula and the needle hub distal end is seated in the needle port,using a single hand to insert the needle and the cannula into the fluiddelivery location; and 3) with the needle and cannula in the fluiddelivery location, using the single hand to push the push feature whilepulling the pull feature to urge the IV catheter system to move from theinsertion configuration to the fluid delivery configuration, in whichthe needle is positioned outside the catheter hub.

In some instances, the catheter hub of the IV catheter system of themethod comprises a catheter hub intermediate portion between thecatheter hub proximal end and the catheter hub distal end, wherein thecatheter component further comprises an extension tubing junctionextending outwardly from the catheter hub intermediate portion toconnect the catheter hub to extension tubing, wherein the push featurecomprises a push surface extending between the catheter hub intermediateportion and the extension tubing junction, wherein the push surface isoriented substantially perpendicular to the axis, wherein pushing thepush feature comprises pressing on the push surface.

In some instances, the catheter component of the IV catheter system ofthe method further comprises a securement platform comprising a firstwing extending from the catheter hub, generally parallel to the axis,wherein urging the IV catheter system to move from the insertionconfiguration to the fluid delivery configuration comprises positioningthe first wing to rest on skin of the patient.

In some instances, in the insertion configuration of the IV cathetersystem of the method, the first wing and the grip are generally parallelto each other and are positioned in abutting relation to each other,wherein urging the IV catheter system to move from the insertionconfiguration to the fluid delivery configuration comprises causing thegrip to slide along the first wing. In some instances, at least one ofthe first wing and the grip comprises one or more alignment features,wherein urging the IV catheter system to move from the insertionconfiguration to the fluid delivery configuration comprises, with theone or more alignment features, causing the first wing and the grip toremain positioned in abutting relation to each other during motion ofthe IV catheter system from the insertion configuration toward the fluiddelivery configuration.

In some instances, at least one of the first wing and the grip of the IVcatheter system of the method comprises one or more locking features,wherein urging the IV catheter system to move from the insertionconfiguration to the fluid delivery configuration comprises providing adisengagement force sufficient to unlock the one or more lockingfeatures.

In some instances, the pull feature of the IV catheter system of themethod further comprises a leading edge of the grip, wherein pulling thepull feature comprises pulling on the leading edge with the single hand.

In a third implementations of the invention, an IV catheter system isprovided comprising an insertion configuration and a fluid deliveryconfiguration, the IV catheter system comprising: a catheter componentcomprising: a catheter hub comprising a catheter hub distal end, acatheter hub proximal end, and a catheter hub intermediate portionbetween the catheter hub proximal end and the catheter hub distal end,wherein the catheter hub is shaped to define a chamber extending betweenthe catheter hub distal end and the catheter hub proximal end, and aneedle port at the catheter hub proximal end that provides access to thechamber; a cannula extending distally from the catheter hub distal end;an extension tubing junction extending outwardly from the catheter hubintermediate portion to connect the catheter hub to extension tubing; aseptum within the chamber; and a push feature protruding outwardly fromthe catheter hub; and a needle component comprising: a needle hubcomprising a needle hub distal end and a needle hub proximal end; aneedle extending distally from the needle hub distal end along an axis;and a grip extending from the needle hub, generally parallel to theaxis, the grip comprising a pull feature defined by a leading edge ofthe grip, wherein, in the insertion configuration, the needle ispositioned within the cannula, the needle passes through the septum, andthe needle hub distal end is seated in the needle port, wherein, in thefluid delivery configuration, the needle is positioned outside thecatheter hub, wherein the push feature is positioned to receive firstcontact from a first digit of a hand of a user to urge the catheter hubdistally and the pull feature is positioned to receive second contactfrom a second digit of the hand simultaneously with receipt of the firstcontact such that the first and second contacts cooperate to urge the IVcatheter system to move from the insertion configuration to the fluiddelivery configuration, wherein the leading edge is shaped and sized tocomfortably receive the second contact, wherein the septum is configuredto provide a sufficiently low resistance to withdrawal of the needlethrough the septum to enable the hand, alone, to move the IV cathetersystem from the insertion configuration to the fluid deliveryconfiguration.

In some instances, the push feature of the IV catheter system furthercomprises a push surface extending between the catheter hub intermediateportion and the extension tubing junction, wherein the push surface isoriented substantially perpendicular to the axis. In some instances, thecatheter component further comprises a securement platform comprising: afirst wing extending from the catheter hub, generally parallel to theaxis such that, in the fluid delivery configuration, the first wingrests on skin of a patient receiving fluid through the IV cathetersystem; and a second wing extending from the catheter hub, generallycoplanar with the first wing such that, in the fluid deliveryconfiguration, the second wing also rests on the skin, wherein, in theinsertion configuration, the first wing and the grip are generallyparallel to each other and are positioned in abutting relation to eachother, wherein, during motion of the IV catheter system from theinsertion configuration to the fluid delivery configuration, the gripslides along the first wing.

In some instances, the catheter hub of the IV catheter system furthercomprises a catheter hub intermediate portion between the catheter hubproximal end and the catheter hub distal end, wherein the cathetercomponent further comprises an extension tubing junction extendingoutwardly from the catheter hub intermediate portion to connect thecatheter hub to extension tubing, and wherein the first wing extendsbetween the catheter hub intermediate portion and the extension tubingjunction but does not extend outwardly beyond the extension tubingjunction.

In some instances, the needle component of the IV catheter systemfurther includes a flash component having a proximal vent and at leastone side vent. In some instances, the catheter component includes avisual indicator. In some instances, the visual indicator is covered bythe needle hub distal end when a tip of the needle extends distallybeyond the cannula and that is exposed when the tip of the needle iswithdrawn into the cannula.

In some instances, the needle component of the IV catheter systemincludes side grips and the catheter component includes a push tab. Insome instances, the needle component includes a flash chamber, the sidegrips being formed on the flash chamber. In some instances, the cathetercomponent further comprises: a securement platform comprising a firstwing extending from the catheter hub, generally parallel to the axissuch that, in the fluid delivery configuration, the first wing rests onskin of a patient receiving fluid through the IV catheter system; and anextension tubing junction extending outwardly from the catheter hubintermediate portion to connect the catheter hub to extension tubing,wherein the extension tubing junction extends in an opposite directionof the first wing.

In some instances, the catheter component of the IV catheter systemfurther comprises a second wing that extends in the opposite directionof the first wing, the second wing incorporating but not extendingbeyond the extension tubing junction. In some instances, the second wingis formed of a rigid material and the first wing is formed of a flexiblematerial. In some instances, the first wing is configured to pivot withrespect to the catheter hub about the axis. In some instances, the firstwing includes a hinge that enables the pivoting. In some instances, thefirst wing is formed of a flexible material that enables the pivoting.

In a fourth implementation of the invention, an IV catheter system isprovided comprising: a catheter component comprising: a catheter hubcomprising a catheter hub distal end and a catheter hub proximal end,wherein the catheter hub is shaped to define a chamber extending betweenthe catheter hub distal end and the catheter hub proximal end, and aneedle port at the catheter hub proximal end that provides access to thechamber; a cannula extending distally from the catheter hub distal end;and a push tab positioned at the catheter hub proximal end; and a needlecomponent comprising: a needle hub comprising a needle hub distal endand a needle hub proximal end, the needle hub distal end including acut-out that aligns with the push tab formed at the catheter hubproximal end; and a needle extending distally from the needle hub distalend along an axis.

In some instances, the catheter component of the IV catheter systemincludes a securement platform. In some instances, the push tab and thesecurement platform are connected via one or more connecting channels.In some instances, the catheter component includes a strain reliefpositioned at the catheter hub distal end around the cannula, the strainrelief being coupled to the securement platform by a connecting channel.In some instances, the catheter component and the needle component eachinclude a protrusion which interface to limit rotation of the needlecomponent relative to the catheter component. In some instances, theneedle component includes a wing and wherein the protrusions prevent thewing from rotating downward below the securement platform. In someinstances, the IV catheter system further comprises a flash componentthat includes a path-defining structure for controlling flow of bloodwithin the flash component.

These and other features and advantages of the present invention may beincorporated into certain embodiments of the invention and will becomemore fully apparent from the following description and appended claims,or may be learned by the practice of the invention as set forthhereinafter. The present invention does not require that all theadvantageous features and all the advantages described herein beincorporated into every embodiment of the invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In order that the manner in which the above-recited and other featuresand advantages of the invention are obtained will be readily understood,a more particular description of the invention briefly described abovewill be rendered by reference to specific embodiments thereof that areillustrated in the appended drawings. These drawings depict only typicalembodiments of the invention and are not therefore to be considered tolimit the scope of the invention.

FIG. 1 is a perspective view of an IV catheter system according to oneembodiment;

FIG. 2 is a perspective view of a portion of an IV catheter systemaccording to one alternative embodiment;

FIGS. 3A and 3B are perspective and plan views, respectively, of aportion of an IV catheter system according to another alternativeembodiment;

FIG. 4 is a plan view of an IV catheter system according to anotheralternative embodiment;

FIG. 5 is a perspective view of an IV catheter system according toanother alternative embodiment;

FIG. 6 is a perspective view of an IV catheter system according toanother alternative embodiment;

FIG. 7 is a perspective view of an IV catheter system according toanother alternative embodiment;

FIG. 8 is a plan view of an IV catheter system according to anotheralternative embodiment;

FIGS. 9A and 9B are perspective and side elevation, section views,respectively, of an IV catheter system according to yet anotheralternative embodiment;

FIGS. 10A, 10B, and 10C are perspective views of an IV catheter systemaccording to still another alternative embodiment, with the cathetercomponent and needle component partially separated, in the insertionconfiguration, and with the catheter component and needle componentpartially separated, respectively; and

FIG. 11 is a flowchart diagram depicting one method of preparing an IVcatheter system to deliver fluid to a patient, according to oneembodiment.

FIGS. 12A and 12B are perspective views of an IV catheter systemaccording to yet another alternative embodiment, in a fully-assembledstate and in an exploded state, respectively.

FIGS. 13A and 13B are perspective views of an IV catheter systemaccording to yet another alternative embodiment, in an open state and acompacted state, respectively.

FIGS. 14A, 14B, 14C, and 14D are perspective views of an IV cathetersystem according to yet another alternative embodiment, in the insertionconfiguration in a compacted state, with the catheter component inisolation, in the insertion configuration in an open state, and with theflash component in an exploded state, respectively.

FIGS. 15A, 15B, 15C, and 15D are perspective views of an IV cathetersystem according to yet another alternative embodiment, in the insertionconfiguration in a compacted state, with the catheter component andneedle component in isolation, in the insertion configuration in an openstate, and with the flash component in an exploded state, respectively.

FIG. 16 is a perspective view of an IV catheter system according tovarious embodiments in which the securement platform includes a wingthat extends only between the catheter component and the extensiontubing junction.

FIG. 17 is a perspective view of an IV catheter system according to yetanother alternative embodiment in which a flash component that isincorporated into a needle component includes side vents.

FIGS. 18A and 18B are perspective and side views respectively of an IVcatheter system according to various embodiments in which the cathetercomponent includes a visual indicator to provide an indication of whenthe needle reaches the hooded position.

FIGS. 19A and 19B are perspective and side views respectively of an IVcatheter system according to various embodiments in which an elongatedflash component includes side grips and the catheter component includesa push tab.

FIG. 20 is a perspective view of an IV catheter system according tovarious embodiments that provide a number of additional features.

FIG. 21 illustrates an example of an anti-rotation feature that can beemployed with one or more embodiments of an IV catheter system.

FIGS. 22A and 22B illustrate how many of the disclosed features can beprovided on an open IV catheter system.

FIG. 23 illustrates a path-defining structure that can be employedwithin a flash chamber in embodiments of an IV catheter system.

FIGS. 24A-24E each illustrate a cross-sectional view of a flash chamberthat includes the path-defining structure of FIG. 23.

FIGS. 25A and 25B illustrate another path-defining structure that can beemployed within a flash chamber in embodiments of an IV catheter system.

FIG. 25C illustrates a cross-sectional view of a flash chamber thatincludes the path-defining structure of FIGS. 25A and 25B.

FIG. 26 illustrates how a vent plug can be employed in conjunction witha path-defining structure.

FIGS. 27A-27C each illustrate different ways in which a path-definingstructure can be secured within a flash chamber.

FIGS. 28A and 28B illustrate how a path-defining structure can include aporous material.

FIG. 29 illustrates how a path-defining structure can be altered todelay when visual confirmation of proper catheter placement is provided.

FIG. 30 illustrates how a sealing cap can be employed on a flash chamberto prevent saline from flowing into the flash chamber when an IVcatheter system is pre-primed.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiments of the present invention can beunderstood by reference to the drawings, wherein like reference numbersindicate identical or functionally similar elements. It will be readilyunderstood that the components of the present invention, as generallydescribed and illustrated in the figures herein, could be arranged anddesigned in a wide variety of different configurations. Thus, thefollowing more detailed description, as represented in the figures, isnot intended to limit the scope of the invention as claimed, but ismerely representative of presently preferred embodiments of theinvention.

Moreover, the Figures may show simplified or partial views, and thedimensions of elements in the Figures may be exaggerated or otherwisenot in proportion for clarity. In addition, the singular forms “a,”“an,” and “the” include plural referents unless the context clearlydictates otherwise. Thus, for example, reference to a terminal includesreference to one or more terminals. In addition, where reference is madeto a list of elements (e.g., elements a, b, c), such reference isintended to include any one of the listed elements by itself, anycombination of less than all of the listed elements, and/or acombination of all of the listed elements.

The term “substantially” means that the recited characteristic,parameter, or value need not be achieved exactly, but that deviations orvariations, including for example, tolerances, measurement error,measurement accuracy limitations and other factors known to those ofskill in the art, may occur in amounts that do not preclude the effectthe characteristic was intended to provide.

As used herein, the term “proximal”, “top”, “up” or “upwardly” refers toa location on the device that is closest to the clinician using thedevice and farthest from the patient in connection with whom the deviceis used when the device is used in its normal operation. Conversely, theterm “distal”, “bottom”, “down” or “downwardly” refers to a location onthe device that is farthest from the clinician using the device andclosest to the patient in connection with whom the device is used whenthe device is used in its normal operation.

As used herein, the term “in” or “inwardly” refers to a location withrespect to the device that, during normal use, is toward the inside ofthe device. Conversely, as used herein, the term “out” or “outwardly”refers to a location with respect to the device that, during normal use,is toward the outside of the device.

FIG. 1 is a perspective view of an IV catheter system 100 according toone embodiment. The IV catheter system 100 may be connected to a supplyof fluid to be infused. The fluid supply (not shown) may include a bagof blood or medication to be delivered to the patient, a drip chamberthat regulates flow of the fluid to the IV catheter system 100, and/orother components involved with the supply of fluid to the IV cathetersystem 100. The IV catheter system 100 may have a number of components,as shown in the exemplary embodiment of FIG. 1. These components mayinclude a catheter component 102, a needle component 104, an extensiontube 106, a clamp 108, and/or a luer lock adapter 110.

The catheter component 102 may be inserted into the fluid deliverylocation in the patient in order to convey the fluid to the patient. Theneedle component 104 may facilitate insertion of the catheter component102 to the fluid delivery location. The extension tube 106 may conveythe fluid to the catheter component 102. The clamp 108 may be used tomanually block fluid flow to the catheter component 102 when it isdesired to stop or pause fluid delivery. The luer lock adapter 110 maybe readily connected to the fluid supply, for example, via connection toa complementary luer lock (not shown) of the fluid supply.

As embodied in FIG. 1, the IV catheter system 100 may be an integratedIV catheter system, as the extension tube 106 is pre-attached to thecatheter component 102. In other embodiments, IV catheter systems ofvarious open, integrated, and/or safety integrated configurations may beused.

The catheter component 102 may have various components, which mayinclude a catheter hub 120, a securement platform 122, an extensiontubing junction 124, and a cannula 126. The catheter hub 120 may have agenerally tubular and/or hollow conical configuration, and may have aproximal end 130 and a distal end 132. The catheter hub 120 may beshaped to define a chamber 134 through which the fluid flows to reachthe fluid delivery location. The catheter hub 120 may have a needle port136 at the proximal end 130. The chamber 134 may contain a septum 138that is designed to block flow of blood and/or the fluid to be deliveredfrom the chamber 134 through the needle port 136. The cannula 126 may besecured to the distal end 132 of the catheter hub 120.

The securement platform 122 may have a generally planar configurationdesigned to permit the securement platform 122 to be secured to the skinof the patient, proximate the fluid delivery location, to keep thecatheter component 102 securely in place as fluid delivery takes place.As embodied in FIG. 1, the securement platform 122 may have a first wing140 with a generally planar shape, and a second wing 142 that also has agenerally planar shape generally coplanar with the first wing 140. Thesecond wing 142 may be positioned on the opposite side of the catheterhub 120 from the first wing 140. Thus, relative to the catheter hub 120,the first wing 140 and the second wing 142 may extend outward inopposite directions from the catheter hub 120. The first wing 140 andthe second wing 142 may both be fixedly secured to the catheter hub 120,and may each have a generally triangular shape when viewed from along adirection perpendicular to the securement platform 122. In thealternative, the first wing 140 and/or the second wing 142 may have anyshape, including but not limited to polygonal shapes such as triangularand rectangular shapes, and non-polygonal shapes such as circular,semicircular, oval, oblong, and irregular shapes. Some examples of thesealternative shapes will be shown in subsequent embodiments. The firstwing 140 and the second wing 142 may each have a trailing edge 144oriented toward the proximal end 130 of the catheter hub 120.

The needle component 104 may have a needle hub 150, a grip 152, and aneedle 154. The needle hub 150 may be detachably coupled to the catheterhub 120 of the catheter component 102. The grip 152 may extend outwardfrom the needle hub 150. The needle 154 may be removably positionedwithin the cannula 126 such that the needle 154 facilitates the processof accessing the fluid delivery location (for example, a vein) andproper positioning of the cannula 126 to deliver the fluid to the fluiddelivery location.

The needle hub 150 may have a generally tubular shape with a proximalend 160 and a distal end 162. The needle hub 150 may have a boss 164positioned at the distal end 162; the boss 164 may be insertable intothe needle port 136 of the catheter hub 120 of the catheter component102.

The grip 152 may have a generally planar shape that extends outward fromthe needle hub 150. When viewed from a direction perpendicular to thegrip 152, the grip 152 may have an oblong and/or partially ellipticalshape. The grip 152, the first wing 140, and/or the second wing 142 mayhave one or more grip features 170, as shown on the grip 252, which mayhelp provide a secure interface that facilitates gripping and/or movingthe grip 152 by hand. The grip 152 may have a leading edge 172.

The IV catheter system 100 may have an insertion configuration, in whichthe IV catheter system 100 is readily insertable to position the cannula126 in the fluid delivery location, and a fluid delivery configuration,in which the fluid flow through the cannula 126 is relatively unimpeded.In FIG. 1, the IV catheter system 100 is in the insertion configuration.The needle 154 is positioned within the cannula 126 to provide asharpened tip for penetrating tissue and a relatively stiff body thatsupports the cannula 126 during insertion. The boss 164 of the needlehub 150 is positioned within the needle port 136 of the catheter hub120. The needle 154 passes through the septum 138 of the cathetercomponent 102.

The IV catheter system 100 may be inserted into position by positioningthe tip of the cannula 126 proximate the fluid delivery location (forexample, the patient's vein). The securement platform 122 may be placedon the patient's skin, proximate the fluid delivery location and/or heldin the clinician's hand. The catheter component 102 and the needlecomponent 104 may be advanced to push the cannula 126 until the tip ofthe cannula 126 penetrates the surrounding tissue and reaches the fluiddelivery location. If desired, the catheter component 102 may beadvanced by pushing a push surface of the catheter component 102. The“push surface” is a surface that is generally proximally-oriented, andthus can receive contact from the clinician's hand to urge the cathetercomponent 102 and the needle component 104, together, distally.

Once the tip of the cannula 126 has reached the fluid delivery location,the IV catheter system 100 may be moved to the fluid deliveryconfiguration. This may be done by withdrawing the needle component 104proximally from the catheter component 102. This may initially cause theboss 164 to be withdrawn proximally from within the needle port 136. Theneedle 154 may also be withdrawn proximally from the cannula 126, andthen through the chamber 134, including the septum 138. The needle 154may pass out of the chamber 134 through the needle port 136, thuscompleting motion of the IV catheter system 100 to the fluid deliveryconfiguration. Fluid flow to the fluid delivery location may now beaccomplished by urging the fluid to flow through the extension tube 106,into the chamber 134, and through the cannula 126 to the fluid deliverylocation.

The IV catheter system 100 may advantageously be designed to facilitateinsertion to the fluid delivery location to be readily performed with asingle hand. For example, during insertion, the clinician may, with onehand, hold the catheter component 102 and the needle component 104, forexample, by grasping the securement platform 122 and the grip 152. Theclinician may then, with the same hand, apply gentle pressure to one ormore push surfaces of the catheter component 102 (for example, thetrailing edges 144 of the first wing 140 and/or the second wing 142) tourge the tip of the cannula 126 to penetrate the patient's skin andultimately reach the fluid delivery location. If desired, one or morelocking features (not shown) may be used to hold the catheter component102 and the needle component 104 together until the clinician applies athreshold force to move the IV catheter system 100 from the insertionconfiguration to the fluid delivery configuration. Such locking featuresmay take the form of interlocking features (not shown) between the boss164 and the needle port 136, and/or the like.

The IV catheter system 100 may be designed to provide visualconfirmation of proper placement in a blood vessel. For example, atleast a portion of the catheter hub 120 may be translucent to providevisibility into the chamber 134. Thus, when the tip of the cannula 126enters a vein, the resulting blood flow, or “flash,” may be visiblethrough the exterior wall of the catheter hub 120 as the blood entersthe chamber 134. The extension tubing junction 124 and the extensiontube 106 may also, optionally, be translucent. In some embodiments, theflash may extend through the extension tube 106 to the luer lock adapter110. The luer lock adapter 110 may be coupled to the fluid supply in amanner that substantially prevents blood leakage.

Further, the IV catheter system 100 may advantageously be designed tofacilitate motion from the insertion configuration to the fluid deliveryconfiguration with a single hand. For example, the clinician may, with asingle hand, which may be the same hand used to insert the IV cathetersystem 100 into the fluid delivery location, grasp the cathetercomponent 102 and the needle component 104 and withdraw the needlecomponent 104 proximally from the catheter component 102. The cathetercomponent 102 may be left substantially in place so that only the needlecomponent 104 moves significantly to move the IV catheter system 100from the insertion configuration to the fluid delivery configuration.

This may be done by placing digits of the hand to contact the pullsurface(s) of the needle component 104 and the push surface(s) of thecatheter component 102, and then with those digits, pulling the needlecomponent 104 proximally while pushing the catheter component 102distally to keep it from moving proximally with the needle component104. For example, the trailing edges 144 of the securement platform 122may act as push surfaces, while the edge 172 of the grip 152 may act asa pull surface. The clinician may place one or more fingers on theleading edge 172 of the grip 152 and pulling proximally, while pushingwith a thumb and/or one or more other fingers on the trailing edges 144of the securement platform 122. Thus, the catheter component 102 may bekept in place with the tip of the cannula 126 at the fluid deliverylocation while the needle component 104 is withdrawn proximally from thecatheter component 102 to unblock the fluid delivery path to the fluiddelivery location.

The relative positions of the pull and push surfaces may facilitatesingle-handed operation in the manner described above. If desired, thecoupling of the needle hub 150 with the catheter hub 120 may be suchthat the needle hub 150 is rotatable relative to the catheter hub 120while the IV catheter system 100 is in the insertion configuration.Thus, the clinician may, with the hand, rotate the grip 152 to anorientation that is most comfortable for pulling on the leading edge172, prior to pulling on the leading edge 172 and pushing on thetrailing edges 144.

The septum 138 may have a “low friction” or “low drag” design configuredto provide relatively low resistance to withdrawal of the needle 154proximally through the septum 138, which occurs as the IV cathetersystem 100 transitions from the insertion configuration to the fluiddelivery configuration. The resistance to withdrawal of the needle 154through the septum 138 may be sufficiently low that the clinician canrelatively easily move the IV catheter system 100 from the insertionconfiguration to the fluid delivery configuration with only a singlehand. In some embodiments, the resistance to withdrawal may be, onaverage, less than about 50 gf.

FIG. 2 is a perspective view of a portion of an IV catheter system 200according to one alternative embodiment. The IV catheter system 200 mayhave components that generally correspond to those of the IV cathetersystem 100 of FIG. 1. FIG. 2 illustrates only a catheter component 202,a needle component 204, and the distal end of an extension tube 206connected to the catheter component 202. The IV catheter system 200 mayhave a configuration similar to that of the IV catheter system 100 ofFIG. 1; however, some components may be shaped differently to providealternative ergonomics.

The catheter component 202 may have a catheter hub 220, a securementplatform 222, an extension tubing junction 224, and a cannula 226. Thecatheter hub 220 may have a generally tubular and/or hollow conicalshape, with a proximal end 230 and a distal end 232. The catheter hub220 may have a generally translucent exterior wall shaped to define achamber 234 through which fluid flows to reach the fluid deliverylocation through the cannula 226. The catheter hub 220 may have a needleport 236 that connects to the needle component 204, proximate theproximal end 230 of the catheter hub 220. The catheter hub 220 may alsohave a septum 238 positioned within the chamber 234. The septum 238 maybe a “low drag” septum as described previously.

The securement platform 222 may be attached to the skin of the patientduring fluid delivery to keep the cannula 226 in place at the fluiddelivery location. The securement platform 222 may have a first wing 240and a second wing 242, which may both be generally planar in shape, andmay extend in opposite directions relative to the catheter hub 220. Eachof the first wing 240 and the second wing 242 may have a generallyrectangular shape when viewed from perpendicular to the securementplatform 222, with a trailing edge 244 that can act as a push surface.

The needle component 204 may have a needle hub 250, a grip 252, and aneedle 254. The needle hub 250 may have a generally cylindrical shapewith a proximal end 260 and a distal end 262. The needle hub 250 mayalso have a boss 264 that protrudes from the distal end 262 to interfacewith the needle port 236 of the catheter hub 220.

The grip 252 may have a generally planar shape, with a generallyrectangular shape when viewed from perpendicular to the grip 252.However, the grip 252 may have any other suitable shape. The grip 252may have a leading edge (not visible), which may serve as a pullsurface. The grip 252, the first wing 240, and/or the second wing 242may have one or more grip features 270, which may help provide a secureinterface that facilitates gripping and/or moving the grip 152 by hand.

To move the IV catheter system 200 from the insertion configuration tothe fluid delivery configuration, the clinician may position a digit(for example, a finger) on the leading edge of the grip 252, and a digit(for example, a finger or thumb) on the trailing edge 244 of the firstwing 240 and/or the second wing 242. The clinician may then pull theleading edge proximally, as indicated by the arrow 290, and may push thetrailing edge 244 of the first wing 240 and/or the second wing 242distally, as indicated by the arrow 292. This may cause the cathetercomponent 202 to remain in place while the needle component 204 iswithdrawn proximally from the catheter component 202.

The grip 252 and the first wing 240 may be positioned parallel to eachother, and may be positioned in close proximity to each other such thatthey are in abutting relation to each other in the insertionconfiguration, and during the initial stages of motion from theinsertion configuration to the fluid delivery configuration. In order tomaintain the desired relative positioning between the grip 252 and thefirst wing 240, the grip 252 and/or the first wing 240 may have one ormore alignment features that maintain relative positioning and/ororientation between the first wing 240 and the grip 252.

Specifically, the grip 252 may have an alignment feature in the form ofan alignment ridge 280, which may protrude toward the first wing 240,and may be received in a complementary alignment feature (not shown)such as a trough or other feature on the surface of the first wing 240that faces toward the grip 252. The alignment ridge 280 and thecomplementary alignment feature may help keep the needle 254 parallel tothe cannula 226 during motion of the IV catheter system 200 to the fluiddelivery configuration. This may help ensure that the needle component204 can be smoothly withdrawn from the catheter component 202. Morespecifically, application of imbalanced force on the catheter component202 and/or the needle component 204 may urge the needle component 204 torotate relative to the catheter component 202. For example, if theclinician is pulling on the leading edge of the grip 252 while pushingon the trailing edge 244 of the first wing 240, this may urge the needlecomponent 204 to rotate clockwise, relative to the view of FIG. 2, withrespect to the catheter component 202.

The alignment ridge 280 and the complementary alignment feature of thefirst wing 240 may help ensure that such relative rotation does notoccur until the needle component 204 has been withdrawn from thecatheter component 202 sufficiently to detach the alignment ridge 280from the complementary alignment feature of the first wing 240. Thus,binding and/or other undesired interactions between the cathetercomponent 202 and the needle component 204 may be avoided during motionfrom the insertion configuration to the fluid delivery configuration.

FIGS. 3A and 3B are perspective and plan views, respectively, of aportion of an IV catheter system 300 according to another alternativeembodiment. The IV catheter system 300 may have components thatgenerally correspond to those of FIGS. 1 and 2. FIGS. 3A and 3Billustrate only a catheter component 302, a needle component 304, andthe distal end of an extension tube 306 connected to the cathetercomponent 302. The IV catheter system 300 may have a configurationsimilar to those of previous embodiments; however, some components maybe shaped differently to provide alternative ergonomics.

As in previous embodiments, the catheter component 302 may have acatheter hub 320, a securement platform 322, an extension tubingjunction 324, and a cannula 326. The catheter hub 320 may have agenerally tubular and/or hollow conical shape, with a proximal end 330and a distal end 332. The catheter hub 320 may have a generallytranslucent exterior wall shaped to define a chamber 334 through whichfluid flows to reach the fluid delivery location through the cannula326. The catheter hub 320 may have a needle port 336 that connects tothe needle component 304, proximate the proximal end 330 of the catheterhub 320. The catheter hub 320 may also have a septum 338 positionedwithin the chamber 334. The septum 338 may be a “low drag” septum asdescribed previously.

The securement platform 322 may be attached to the skin of the patientduring fluid delivery to keep the cannula 326 in place at the fluiddelivery location. The securement platform 322 may have only a singlewing in the form of a first wing 340, which may be generally planar inshape, and may have a generally trapezoidal shape when viewed fromperpendicular to the securement platform 322, with a trailing edge 344that can act as a push surface.

The first wing 340 may be integrated with the extension tubing junction324 such that the extension tubing junction 324 defines a leading edgeof the first wing 340. The extension tubing junction 324 may provide anenlargement to the width of the first wing 340 at the leading edge; thisenlargement may enable the extension tubing junction 324 to serve as apush surface. More specifically, the clinician may push on the trailingportion of the extension tubing junction 324, where the extension tubingjunction 324 merges with the first wing 340, to urge the cathetercomponent 302 forward.

The needle component 304 may have a needle hub 350, a grip 352, and aneedle 354. The needle hub 350 may have a generally cylindrical shapewith a proximal end 360 and a distal end 362. The needle hub 350 mayalso have a boss 364 that protrudes from the distal end 362 to interfacewith the needle port 336 of the catheter hub 320.

The grip 352 may have a generally planar shape, with a generallytrapezoidal shape when viewed from perpendicular to the grip 352. Thegrip 352 may have a leading edge 372, which may serve as a pull surface.The grip 352 and/or the first wing 340 may have one or more gripfeatures 370, which may help provide a secure interface that facilitatesgripping and/or moving the grip 152 by hand.

To move the IV catheter system 300 from the insertion configuration tothe fluid delivery configuration, the clinician may position a digit(for example, a finger) on the leading edge 372 of the grip 352 and/oron the leading edge of the tab 384, and a digit (for example, a fingeror thumb) on the trailing edge 344 of the first wing 340. The clinicianmay then pull the leading edge 372 and/or the leading edge of the tab384 proximally, and may push the trailing edge 344 of the first wing 340distally. This may cause the catheter component 302 to remain in placewhile the needle component 304 is withdrawn proximally from the cathetercomponent 302.

The grip 352 and the first wing 340 may be positioned parallel to eachother, and may be positioned in close proximity to each other such thatthey are in abutting relation to each other in the insertionconfiguration, and during the initial stages of motion from theinsertion configuration to the fluid delivery configuration. In order tomaintain the desired relative positioning between the grip 352 and thefirst wing 340, the grip 352 and/or the first wing 340 may have one ormore alignment features that maintain relative positioning and/ororientation between the first wing 340 and the grip 352.

Specifically, the grip 352 may have an alignment feature in the form ofa pair of alignment ridges 380, which may protrude toward the first wing340, and may be received in complementary alignment features in the formof slots 382 formed in the first wing 340. The alignment ridges 380 andthe slots 382 may help keep the needle component 304 parallel to thecatheter component 302 during motion of the IV catheter system 300 tothe fluid delivery configuration, which may facilitate motion to thefluid delivery configuration as described in the previous embodiment.

If desired, the first wing 340 may be translucent so as to facilitateuser visualization of the grip 352, and more specifically, of the edge372. In addition to the leading edge 372, the needle component 304 mayhave a tab 384 that protrudes outward from the needle hub 350 in adirection generally opposite to that in which the grip 352 protrudes.The tab 384 may provide a pull surface that can be used by a clinician,in addition to and/or in the alternative to the leading edge 372 of thegrip 352. This may provide additional options for the clinician toinsert the IV catheter system 300 with a single hand and/or to move theIV catheter system 300 from the insertion configuration to the fluiddelivery configuration with a single hand.

FIG. 4 is a plan view of an IV catheter system 400 according to anotheralternative embodiment. The IV catheter system 400 may have componentssimilar to those of the IV catheter system 300 of FIGS. 3A and 3B. FIG.4 illustrates only a catheter component 402, a needle component 404, andthe distal end of an extension tube 406 connected to the cathetercomponent 402. The IV catheter system 400 may have a configurationsimilar to that of the IV catheter system 300; however, some componentsmay be shaped differently to provide alternative ergonomics.

As in previous embodiments, the catheter component 402 may have acatheter hub 420, a securement platform 422, an extension tubingjunction 424, and a cannula 426. The catheter hub 420 may have agenerally tubular and/or hollow conical shape, with a proximal end 430and a distal end 432. The catheter hub 420 may have a generallytranslucent exterior wall shaped to define a chamber 434 through whichfluid flows to reach the fluid delivery location through the cannula426. The catheter hub 420 may have a needle port 436 that connects tothe needle component 404, proximate the proximal end 430 of the catheterhub 420. The catheter hub 420 may also have a septum 438 positionedwithin the chamber 434. The septum 438 may be a “low drag” septum asdescribed previously.

The securement platform 422 may be attached to the skin of the patientduring fluid delivery to keep the cannula 426 in place at the fluiddelivery location. The securement platform 422 may have only a singlewing in the form of a first wing 440, which may be generally planar inshape, and may have a generally triangular shape when viewed fromperpendicular to the securement platform 422, with a trailing edge 444that can act as a push surface.

The first wing 440 may be integrated with the extension tubing junction424 such that the extension tubing junction 424 defines a leading edgeof the first wing 440. The extension tubing junction 424 may provide anenlargement to the width of the first wing 440 at the leading edge; thisenlargement may enable the extension tubing junction 424 to serve as apush surface. More specifically, the clinician may push on the trailingportion of the extension tubing junction 424, where the extension tubingjunction 424 merges with the first wing 440, to urge the cathetercomponent 402 forward.

The needle component 404 may have a needle hub 450, a grip 452, and aneedle 454. The needle hub 450 may have a generally cylindrical shapewith a proximal end 460 and a distal end 462. The needle hub 450 mayalso have a boss 464 that protrudes from the distal end 462 to interfacewith the needle port 436 of the catheter hub 420.

The grip 452 may have a generally planar shape, with a generallytriangular shape when viewed from perpendicular to the grip 452. Thegrip 452 may have a leading edge 472, which may serve as a pull surface.The grip 452 and/or the first wing 440 may have one or more gripfeatures 470, which may help provide a secure interface that facilitatesgripping and/or moving the grip 452 by hand.

To move the IV catheter system 400 from the insertion configuration tothe fluid delivery configuration, the clinician may position a digit(for example, a finger) on the leading edge 472 of the grip 452 and/orthe leading edge of the tab 484, and a digit (for example, a finger orthumb) on the trailing edge 444 of the first wing 440. The clinician maythen pull the leading edge 472 and/or the leading edge of the tab 484proximally, and may push the trailing edge 444 of the first wing 440distally. This may cause the catheter component 402 to remain in placewhile the needle component 404 is withdrawn proximally from the cathetercomponent 402.

The grip 452 and the first wing 440 may be positioned parallel to eachother, and may be positioned in close proximity to each other such thatthey are in abutting relation to each other in the insertionconfiguration, and during the initial stages of motion from theinsertion configuration to the fluid delivery configuration. In order tomaintain the desired relative positioning between the grip 452 and thefirst wing 440, the grip 452 and/or the first wing 440 may have one ormore alignment features that maintain relative positioning and/ororientation between the first wing 440 and the grip 452.

Specifically, the grip 452 may have an alignment feature in the form ofa pair of alignment ridges 480, which may protrude toward the first wing440, and may be received in complementary alignment features in the formof slots 482 formed in the first wing 440. The alignment ridges 480 andthe slots 482 may help keep the needle component 404 parallel to thecatheter component 402 during motion of the IV catheter system 400 tothe fluid delivery configuration, which may facilitate motion to thefluid delivery configuration as described in the previous embodiment.

If desired, the first wing 440 may be translucent so as to facilitateuser visualization of the grip 452, and more specifically, of the edge472. In addition to the leading edge 472, the needle component 404 mayhave a tab 484 that protrudes outward from the needle hub 450 in adirection generally opposite to that in which the grip 452 protrudes.The tab 484 may provide a pull surface that can be used by a clinician,in addition to and/or in the alternative to the leading edge 472 of thegrip 452. This may provide additional options for the clinician toinsert the IV catheter system 400 with a single hand and/or to move theIV catheter system 400 from the insertion configuration to the fluiddelivery configuration with a single hand.

By comparison with the IV catheter system 300 of FIGS. 3A and 3B, thefirst wing 440 and the grip 452 may have a more triangular, swept shape,as shown. This different shape may cause the leading edge 472 of thegrip 452 to be positioned at a different angle and/or position, whichmay facilitate single-handed operation for some users. Further, in theIV catheter system 400 of FIG. 4, the alignment ridges 480 may berelatively short, thereby providing low frictional resistance to motionof the IV catheter system 400 from the insertion configuration to thefluid delivery configuration.

FIG. 5 is a perspective view of an IV catheter system 500 according toanother alternative embodiment. The IV catheter system 500 may havecomponents similar to those of the IV catheter systems of previousembodiments. FIG. 5 illustrates only a catheter component 502, a needlecomponent 504, and the distal end of an extension tube 506 connected tothe catheter component 502.

As in previous embodiments, the catheter component 502 may have acatheter hub 520, a securement platform 522, an extension tubingjunction 524, and a cannula 526. The catheter hub 520 may have agenerally tubular and/or hollow conical shape, with a proximal end 530and a distal end 532. The catheter hub 520 may have a generallytranslucent exterior wall shaped to define a chamber 534 through whichfluid flows to reach the fluid delivery location through the cannula526. The catheter hub 520 may have a needle port 536 that connects tothe needle component 504, proximate the proximal end 530 of the catheterhub 520. The catheter hub 520 may also have a septum 538 positionedwithin the chamber 534. The septum 538 may be a “low drag” septum asdescribed previously.

The securement platform 522 may be attached to the skin of the patientduring fluid delivery to keep the cannula 526 in place at the fluiddelivery location. The securement platform 522 may have a first wing 540and a second wing 542, each of which may be generally planar in shape.The first wing 540 and the second wing 542 may each have a generallytrapezoidal shape when viewed from perpendicular to the securementplatform 522, with a trailing edge 544 that can act as a push surface.

The first wing 540 may be integrated with the extension tubing junction524 such that the extension tubing junction 524 defines a leading edgeof the first wing 540. The extension tubing junction 524 may provide anenlargement to the width of the first wing 540 at the leading edge; thisenlargement may enable the extension tubing junction 524 to serve as apush surface. More specifically, the clinician may push on the trailingportion of the extension tubing junction 524, where the extension tubingjunction 524 merges with the first wing 540, to urge the cathetercomponent 502 forward.

The second wing 542 may be rotatably coupled to the catheter hub 520.Thus, the clinician may position the second wing 542 at substantiallyany orientation about the axis defined by the cannula 526 and/or theneedle 554. The second wing 542 may rotate relatively freely about thecatheter hub 520 such that the clinician can rotate the second wing 542,relative to the first wing 540, with a single hand to obtain the desiredgrip prior to and/or during insertion of the IV catheter system 500 intothe fluid delivery location and/or motion of the IV catheter system 500from the insertion configuration to the fluid delivery configuration.

The needle component 504 may have a needle hub 550, a grip 552, and aneedle 554. The needle hub 550 may have a generally cylindrical shapewith a proximal end 560 and a distal end 562. The needle hub 550 mayalso have a boss 564 that protrudes from the distal end 562 to interfacewith the needle port 536 of the catheter hub 520.

The grip 552 may have a generally planar shape, with a generallytrapezoidal shape when viewed from perpendicular to the grip 552. Thegrip 552 may have a leading edge 572, which may serve as a pull surface.The grip 552 and/or the first wing 540 may have one or more gripfeatures 570, which may help provide a secure interface that facilitatesgripping and/or moving the grip 552 by hand.

The grip 552 and the first wing 540 may be positioned parallel to eachother, and may be positioned in close proximity to each other such thatthey are in abutting relation to each other in the insertionconfiguration, and during the initial stages of motion from theinsertion configuration to the fluid delivery configuration. In order tomaintain the desired relative positioning between the grip 552 and thefirst wing 540, the grip 552 and/or the first wing 540 may have one ormore alignment features that maintain relative positioning and/ororientation between the first wing 540 and the grip 552.

Specifically, the grip 552 may have an alignment feature in the form ofa pair of alignment ridges 580, which may protrude toward the first wing540, and may be received in complementary alignment features in the formof slots 582 formed in the first wing 540. The alignment ridges 580 andthe slots 582 may help keep the needle component 504 parallel to thecatheter component 502 during motion of the IV catheter system 500 tothe fluid delivery configuration, which may facilitate motion to thefluid delivery configuration as described in the previous embodiment.

If desired, the first wing 540 and/or the second wing 542 may betranslucent so as to facilitate user visualization of the grip 552, andmore specifically, of the edge 572. In addition to the leading edge 572,the needle component 504 may have a tab 584 that protrudes outward fromthe needle hub 550 in a direction generally opposite to that in whichthe grip 552 protrudes. The tab 584 may provide a pull surface that canbe used by a clinician, in addition to and/or in the alternative to theleading edge 572 of the grip 552. This may provide additional optionsfor the clinician to insert the IV catheter system 500 with a singlehand and/or to move the IV catheter system 500 from the insertionconfiguration to the fluid delivery configuration with a single hand.

To move the IV catheter system 500 from the insertion configuration tothe fluid delivery configuration, the clinician may position a digit(for example, a finger) on the leading edge 572 of the grip 552 and/orthe leading edge of the tab 584, and a digit (for example, a finger orthumb) on the trailing edge 544 of the first wing 540. The clinician maythen pull the leading edge 572 and/or the leading edge of the tab 484proximally, and may push the trailing edge 544 of the first wing 540distally. This may cause the catheter component 502 to remain in placewhile the needle component 504 is withdrawn proximally from the cathetercomponent 502.

FIG. 6 is a perspective view of an IV catheter system 600 according toanother alternative embodiment. The IV catheter system 600 may havecomponents similar to those of the IV catheter systems of previousembodiments. FIG. 6 illustrates only a catheter component 602, a needlecomponent 604, and the distal end of an extension tube 606 connected tothe catheter component 602.

As in previous embodiments, the catheter component 602 may have acatheter hub 620, a securement platform 622, an extension tubingjunction 624, and a cannula 626. The catheter hub 620 may have agenerally tubular and/or hollow conical shape, with a proximal end 630and a distal end 632. The catheter hub 620 may have a generallytranslucent exterior wall shaped to define a chamber (not visible)through which fluid flows to reach the fluid delivery location throughthe cannula 626. The catheter hub 620 may have a needle port 636 thatconnects to the needle component 604, proximate the proximal end 630 ofthe catheter hub 620. The catheter hub 620 may also have a septum (notvisible) positioned within the chamber. The septum may be a “low drag”septum as described previously. Further, the catheter hub 620 may have akink resistance feature that helps to avoid kinking of the cannula 626during insertion and/or infusion. The kink resistance feature may takethe form of a proximal extension 628 on the distal end 632 of thecatheter hub 620. The proximal extension 628 may receive the cannula626, and may provide some resistance to bending of the cannula 626 atthe juncture of the cannula 626 to the proximal end 630 to relieve thebending strain at that location, thereby helping avoid kinking or otherundesired bending of the cannula 626.

The securement platform 622 may be attached to the skin of the patientduring fluid delivery to keep the cannula 626 in place at the fluiddelivery location. The securement platform 622 may have a first wing 640and a second wing 642, each of which may be generally planar in shape.The first wing 640 and the second wing 642 may each have a generallytriangular shape when viewed from perpendicular to the securementplatform 622, with a trailing edge 644 that can act as a push surface.The first wing 640 and the second wing 642 may extend in oppositedirections, outward from the axis of the catheter hub 620.

The second wing 642 may be integrated with the extension tubing junction624 such that the extension tubing junction 624 passes through thetrailing edge 644 of the second wing 642. The extension tubing junction624 may provide an enlargement to the width of the second wing 642proximate the trailing edge 644; this enlargement may enable theextension tubing junction 624 to serve as a push surface. Further, thecatheter component 602 may have a push feature in the form of a pushsurface 646 that extends between the extension tubing junction 624 andthe intermediate portion of the catheter hub 620, between the proximalend 630 and the distal end 632. The push surface 646 may have a sizeselected to enable the clinician to relatively easily push on the pushsurface 646 with a digit to urge the catheter component 602 forward. Thepush surface 646 may be oriented substantially perpendicular to the axisof the catheter component 602 and the needle component 604.

The needle component 604 may have a needle hub 650, a grip 652, and aneedle (not visible). The needle hub 650 may have a generallycylindrical shape with a proximal end 660 and a distal end 662. Theneedle hub 650 may also have a boss 664 that protrudes from the distalend 662 to interface with the needle port 636 of the catheter hub 620.

The grip 652 may have a generally planar shape, with a generallyirregular shape when viewed from perpendicular to the grip 652. The grip652 may have a narrow portion 666 that extends from the needle hub 650to connect to a larger portion 668 that lies in abutting relation to thefirst wing 640 of the securement platform 622 when the IV cathetersystem 600 is in the insertion configuration. The grip 652 may have aleading edge 672, which may serve as a pull surface. The grip 652 and/orthe first wing 640 may have one or more grip features (not shown), whichmay help provide a secure interface that facilitates gripping and/ormoving the grip 652 by hand.

To move the IV catheter system 600 from the insertion configuration tothe fluid delivery configuration, the clinician may position a digit(for example, a finger) on the leading edge 672 of the grip 652, and adigit (for example, a finger or thumb) on the trailing edge 644 of thefirst wing 640 and/or the push surface 646. The clinician may then pullthe leading edge 672 proximally, and may push the trailing edge 644and/or the push surface 646 distally. This may cause the cathetercomponent 602 to remain in place while the needle component 604 iswithdrawn proximally from the catheter component 602.

FIG. 7 is a perspective view of an IV catheter system 700 according toanother alternative embodiment. The IV catheter system 700 may havecomponents similar to those of the IV catheter systems of previousembodiments. FIG. 7 illustrates only a catheter component 702, a needlecomponent 704, and the distal end of an extension tube 706 connected tothe catheter component 702.

As in previous embodiments, the catheter component 702 may have acatheter hub 720, a securement platform 722, an extension tubingjunction 724, and a cannula 726. The catheter hub 720 may have agenerally tubular and/or hollow conical shape, with a proximal end 730and a distal end 732. The catheter hub 720 may have a generallytranslucent exterior wall shaped to define a chamber (not visible)through which fluid flows to reach the fluid delivery location throughthe cannula 726. The catheter hub 720 may have a needle port 736 thatconnects to the needle component 704, proximate the proximal end 730 ofthe catheter hub 720. The catheter hub 720 may also have a septum (notvisible) positioned within the chamber. The septum may be a “low drag”septum as described previously. Further, the catheter hub 720 may have akink resistance feature that helps to avoid kinking of the cannula 726during insertion and/or infusion. The kink resistance feature may takethe form of a proximal extension 728 on the distal end 732 of thecatheter hub 720. The proximal extension 728 may receive the cannula726, and may provide some resistance to bending of the cannula 726 atthe juncture of the cannula 726 to the proximal end 730 to relieve thebending strain at that location, thereby helping avoid kinking or otherundesired bending of the cannula 726.

The securement platform 722 may be attached to the skin of the patientduring fluid delivery to keep the cannula 726 in place at the fluiddelivery location. The securement platform 722 may have a first wing 740and a second wing 742, each of which may be generally planar in shape.The first wing 740 and the second wing 742 may each have a generallytriangular shape when viewed from perpendicular to the securementplatform 722, with a trailing edge 744 that can act as a push surface.The first wing 740 and the second wing 742 may extend in oppositedirections, outward from the axis of the catheter hub 720.

The second wing 742 may be integrated with the extension tubing junction724 such that the extension tubing junction 724 passes through thetrailing edge 744 of the second wing 742. The extension tubing junction724 may provide an enlargement to the width of the second wing 742proximate the trailing edge 744; this enlargement may enable theextension tubing junction 724 to serve as a push surface. Further, thecatheter component 702 may have a push feature in the form of a pushsurface 746 that extends between the extension tubing junction 724 andthe intermediate portion of the catheter hub 720, between the proximalend 730 and the distal end 732. The push surface 746 may have a sizeselected to enable the clinician to relatively easily push on the pushsurface 746 with a digit to urge the catheter component 702 forward. Thepush surface 746 may be oriented substantially perpendicular to the axisof the catheter component 702 and the needle component 704.

The needle component 704 may have a needle hub 750, a grip 752, and aneedle (not visible). The needle hub 750 may have a generallycylindrical shape with a proximal end 760 and a distal end 762. Theneedle hub 750 may also have a boss 764 that protrudes from the distalend 762 to interface with the needle port 736 of the catheter hub 720.

The grip 752 may have a generally planar shape, with a generallyirregular shape when viewed from perpendicular to the grip 752. The grip752 may have a narrow portion 766 that extends from the needle hub 750to connect to a larger portion 768 that lies in abutting relation to thefirst wing 740 of the securement platform 722 when the IV cathetersystem 700 is in the insertion configuration. The grip 752 may have aleading edge 772, which may serve as a pull surface. The grip 752 and/orthe first wing 740 may have one or more grip features (not shown), whichmay help provide a secure interface that facilitates gripping and/ormoving the grip 752 by hand.

The first wing 740 and/or the grip 752 may have one or more lockingfeatures that help to keep the IV catheter system 700 in the insertionconfiguration until the clinician applies a threshold disengagementforce sufficient to detach the needle component 704 from the cathetercomponent 702. As shown, the locking features may include a locking tab780 on the first wing 740 and a locking tab 782 on the grip 752. In theinsertion configuration, the locking tab 780 of the first wing 740 mayoverhang the locking tab 782 of the 752. The locking tab 780 and thelocking tab 782 may be interlocked in the insertion configuration suchthat one or both of the locking tab 780 and the locking tab 782 mustflex to permit the locking tab 780 and the locking tab 782 to disengagefrom each other.

To move the IV catheter system 700 from the insertion configuration tothe fluid delivery configuration, the clinician may position a digit(for example, a finger) on the leading edge 772 of the grip 752, and adigit (for example, a finger or thumb) on the trailing edge 744 of thefirst wing 740 and/or the push surface 746. The clinician may then pullthe leading edge 772 proximally, and may push the trailing edge 744and/or the push surface 746 distally. Application of the requiredthreshold disengagement force may disengage the locking tab 782 from thelocking tab 780, thereby permitting the needle component 704 to moveproximally with respect to the catheter component 702. The cathetercomponent 702 may then remain in place while the needle component 704 iswithdrawn proximally from the catheter component 702.

FIG. 8 is a plan view of an IV catheter system 800 according to anotheralternative embodiment. The IV catheter system 800 may have componentssimilar to those of the IV catheter systems of previous embodiments.FIG. 8 illustrates only a catheter component 802, a needle component804, and the distal end of an extension tube 806 connected to thecatheter component 702.

As in previous embodiments, the catheter component 802 may have acatheter hub 820, an extension tubing junction 824, and a cannula 826.However, the catheter component 802 may not have a securement platform.Thus, the presence of a securement platform is optional. If desired, thecatheter hub 820 may instead be secured directly to the patient's skinto keep the cannula 826 in place at the fluid delivery location.

The catheter hub 820 may have a generally tubular and/or hollow conicalshape, with a proximal end 830 and a distal end 832. The catheter hub820 may have a generally translucent exterior wall shaped to define achamber 834 through which fluid flows to reach the fluid deliverylocation through the cannula 826. The catheter hub 820 may have a needleport 836 that connects to the needle component 804, proximate theproximal end 830 of the catheter hub 820. The catheter hub 820 may alsohave a septum 838 positioned within the chamber. The septum 838 may be a“low drag” septum as described previously.

The catheter component 802 may have a push feature in the form of a pushsurface 846 that extends between the extension tubing junction 824 andthe intermediate portion of the catheter hub 820, between the proximalend 830 and the distal end 832. The push surface 846 may have a sizeselected to enable the clinician to relatively easily push on the pushsurface 846 with a digit to urge the catheter component 802 forward. Thepush surface 846 may be oriented substantially perpendicular to the axisof the catheter component 802 and the needle component 804.

The needle component 804 may have a needle hub 850, a grip 852, and aneedle 854. The needle hub 850 may have a generally cylindrical shapewith a proximal end 860 and a distal end 862. The needle hub 850 mayalso have a boss 864 that protrudes from the distal end 862 to interfacewith the needle port 836 of the catheter hub 820.

The grip 852 may have a generally planar shape, with a generallyirregular shape when viewed from perpendicular to the grip 852. The grip852 may have a narrow portion 866 that extends from the needle hub 850to connect to a larger portion 868 that may be coupled to the extensiontubing junction 824 when the IV catheter system 800 is in the insertionconfiguration. The grip 852 may have a leading edge 872, which may serveas a pull surface. The grip 852 may have one or more grip features 870,which may help provide a secure interface that facilitates grippingand/or moving the grip 852 by hand.

Further, the grip 852 may have a recess 874 that receives the extensiontubing junction 824 when the IV catheter system 800 is in the insertionconfiguration. The recess 874 may be shaped to receive the extensiontubing junction 824 and the push surface 846 to maintain alignmentbetween the catheter component 802 and the needle component 804 duringinsertion. Positioning of the extension tubing junction 824 and the pushsurface 846 within the recess 874 may interfere with relative axialmotion between the catheter component 802 and the needle component 804.Thus, when the IV catheter system 800 is to be moved from the insertionconfiguration to the fluid delivery configuration, the needle component804 (and thence, the grip 852 with the recess 874) may be rotatedrelative to the catheter component 802 to withdraw the extension tubingjunction 824 and the push surface 846 from within the recess 874.Proximal motion of the needle component 804 relative to the cathetercomponent 802 may then be unimpeded. In some embodiments, however, theneedle component 804 does not require rotation relative to the cathetercomponent 802 in order to withdraw the extension tubing junction 824 andthe push surface 846 from within the recess 874 (e.g., due to theflexibility of the extension tubing junction 824 and the push surface846).

In addition to the leading edge 872, the needle component 804 may have atab 884 that protrudes outward from the needle hub 850 in a directiongenerally opposite to that in which the grip 852 protrudes. The tab 884may provide a pull surface that can be used by a clinician, in additionto and/or in the alternative to the leading edge 872 of the grip 852.This may provide additional options for the clinician to insert the IVcatheter system 800 with a single hand and/or to move the IV cathetersystem 800 from the insertion configuration to the fluid deliveryconfiguration with a single hand.

To move the IV catheter system 800 from the insertion configuration tothe fluid delivery configuration, the clinician may first rotate theneedle component 804 relative to the catheter component 802 to withdrawthe extension tubing junction 824 and the push surface 846 from withinthe recess 874 as described above. Then, the clinician may position adigit (for example, a finger) on the leading edge 872 of the grip 852and/or on the leading edge of the tab 884, and a digit (for example, afinger or thumb) on the push surface 846. The clinician may then pullthe leading edge 872 and/or the tab 884 proximally, and may push thepush surface 846 distally. The catheter component 802 may then remain inplace while the needle component 804 is withdrawn proximally from thecatheter component 802.

FIGS. 9A and 9B are perspective and side elevation, section views,respectively, of an IV catheter system 900 according to yet anotheralternative embodiment. The IV catheter system 900 may have componentssimilar to those of the IV catheter systems of previous embodiments.FIGS. 9A and 9B illustrate only a catheter component 902 and a needlecomponent 904. The IV catheter system 900 may be an open system ratherthan an integrated system; hence, the IV catheter system may not have anintegrated extension tube or extension tubing junction.

As in previous embodiments, the catheter component 902 may have acatheter hub 920, a tab 924, and a cannula 926. However, as in the IVcatheter system 800, the catheter component 902 may not have asecurement platform. If desired, the catheter hub 920 may be secureddirectly to the patient's skin to keep the cannula 926 in place at thefluid delivery location.

The catheter hub 920 may have a generally tubular and/or hollow conicalshape, with a proximal end 930 and a distal end 932. The catheter hub920 may have a generally translucent exterior wall shaped to define achamber 934 through which fluid flows to reach the fluid deliverylocation through the cannula 926. The catheter hub 920 may have a needleport 936 that connects to the needle component 904, proximate theproximal end 930 of the catheter hub 920. The catheter hub 920 may havea septum 938, which may be a “low drag” septum as described previously.

In alternative implementations (not shown), the catheter hub 920 may nothave a septum. Rather, fluid may flow through the body of the catheterhub 920, from the proximal end 930 to the distal end 932, to reach thecannula 926. After the cannula 926 has been positioned at the fluiddelivery location and the needle component 804 has been withdrawn fromthe catheter component 802, the fluid supply may be connected to theneedle port 936 of the catheter hub 920 to supply the fluid to beinfused to the proximal end 930 of the catheter hub 920.

The tab 924 may extend outward from the catheter hub 920, and mayprovide a ready gripping surface that facilitates user manipulation ofthe catheter hub 920. The tab 924 may have a main portion 940 and anupraised distal end 942. A plurality of grip features 944 may bepositioned on the main portion 940 and the distal end 942. The tab 924may serve as a push feature that can be readily pushed with a digit of ahand to facilitate insertion of the IV catheter system 900 and/or motionof the IV catheter system 900 from the insertion configuration to thefluid delivery configuration. The user may place a digit on the mainportion 940 and/or on the upraised distal end 942 of the tab 924.Further, the shape of the upraised distal end 942 may define a pushsurface 946 oriented substantially perpendicular to the axis of thecannula 926. The user may place a digit on the main portion 940,abutting the push surface 946, to facilitate exertion of forward (i.e.,distal) pressure on the catheter component 902.

The needle component 904 may have a needle hub 950, a first grip 952, asecond grip 953, and a needle 954. The needle hub 950 may have agenerally cylindrical shape with a proximal end 960 and a distal end962. The needle hub 950 may also have a boss 964 that protrudes from thedistal end 962 to interface with the needle port 936 of the catheter hub920.

The first grip 952 and the second grip 953 may each have a generallyplanar shape, with an irregular shape when viewed from perpendicular tothe first grip 952 and the second grip 953. Each of the first grip 952and the second grip 953 may have a narrow portion 966 that extends fromthe needle hub 950 to connect to a larger portion 968. The first grip952 and the second grip 953 may each have a leading edge 972, which mayserve as a pull surface. The leading edges 972 of the first grip 952 andthe second grip 953 may cooperate to define a single continuous surfacethat extends around the periphery of the distal end 932 of the catheterhub 920 to connect the first grip 952 to the second grip 953. Thisinterconnection between the first grip 952 and the second grip 953,which is more clearly shown in FIG. 9B, may act as a kink-resistantfeature and/or provide additional support tending to keep the needlecomponent 904 and the catheter component 902 parallel during insertionand/or transition from the insertion configuration to the fluid deliveryconfiguration.

To move the IV catheter system 900 from the insertion configuration tothe fluid delivery configuration, the clinician may position a digit(for example, a finger) on the leading edge 972 of the first grip 952and/or the leading edge 972 of the second grip 953, and a digit (forexample, a finger or thumb) on the tab 924 (for example, on the pushsurface 946). The clinician may then pull the leading edge 972proximally, and may push the push surface 946 distally. The cathetercomponent 902 may then remain in place while the needle component 904 iswithdrawn proximally from the catheter component 902.

FIGS. 10A, 10B, and 10C are perspective views of an IV catheter system1000 according to still another alternative embodiment, with thecatheter component 1002 and needle component 1004 partially separated,in the insertion configuration, and with the catheter component 1002 andneedle component 1004 partially separated, respectively. The IV cathetersystem 1000 may have components similar to those of the IV cathetersystems of previous embodiments. FIG. 6 illustrates only a cathetercomponent 1002, a needle component 1004, and the distal end of anextension tube 1006 connected to the catheter component 1002.

As in previous embodiments, the catheter component 1002 may have acatheter hub 1020, a securement platform 1022, an extension tubingjunction 1024, and a cannula 1026. The catheter hub 1020 may have agenerally tubular and/or hollow conical shape, with a proximal end 1030and a distal end 1032. The catheter hub 1020 may have a generallytranslucent exterior wall shaped to define a chamber 1034 through whichfluid flows to reach the fluid delivery location through the cannula1026. The catheter hub 1020 may have a needle port 1036 that connects tothe needle component 1004, proximate the proximal end 1030 of thecatheter hub 1020. The catheter hub 1020 may also have a septum 1038positioned within the chamber 1034. The septum may be a “low drag”septum as described previously.

Further, the catheter hub 1020 may have a kink resistance feature thathelps to avoid kinking of the cannula 1026 during insertion and/orinfusion. The kink resistance feature may take the form of a proximalextension 1028 on the distal end 1032 of the catheter hub 1020. Theproximal extension 1028 may receive the cannula 1026, and may providesome resistance to bending of the cannula 1026 at the juncture of thecannula 1026 to the proximal end 1030 to relieve the bending strain atthat location, thereby helping avoid kinking or other undesired bendingof the cannula 1026.

The securement platform 1022 may be attached to the skin of the patientduring fluid delivery to keep the cannula 1026 in place at the fluiddelivery location. The securement platform 1022 may have a first wing1040 and a second wing 1042, each of which may be generally planar inshape. The first wing 1040 and the second wing 1042 may each have atrailing edge 1044 that can act as a push surface. The first wing 1040and the second wing 1042 may extend in opposite directions, outward fromthe axis of the catheter hub 1020. The first wing 1040 may be adjacentto the extension tubing junction 1024.

The needle component 1004 may have a needle hub 1050, a grip 1052, and aneedle 1054. The needle hub 1050 may have a generally cylindrical shapewith a proximal end 1060 and a distal end 1062. The needle hub 1050 mayalso have a boss 1064 that protrudes from the distal end 1062 tointerface with the needle port 1036 of the catheter hub 1020. Betweenthe proximal end 1060 and the distal end 1062, the needle hub 1050 mayhave a plurality of ridges 1066 that protrude outwardly. The needle hub1050 may be elongated so that the user can grip the ridges 1066 at anyof various locations along the length of the needle hub 1050. The ridges1066, or more specifically, the distally-facing surfaces of the ridges1066, may optionally act as pull surfaces 1068 that facilitate grippingof the needle component 1004 to move the IV catheter system 1000 fromthe insertion configuration to the fluid delivery configuration.

The grip 1052 may have a generally planar shape, with a generallyrectangular shape when viewed from perpendicular to the grip 1052. Thegrip 1052 may lie in abutting relation to the first wing 1040 of thesecurement platform 1022 when the IV catheter system 1000 is in theinsertion configuration. The grip 1052 may have a leading edge 1072,which may serve as a pull surface. The grip 1052 and/or the first wing1040 may have one or more grip features (not shown), which may helpprovide a secure interface that facilitates gripping and/or moving thegrip 1052 by hand.

To move the IV catheter system 1000 from the insertion configuration tothe fluid delivery configuration, the clinician may position a digit(for example, a finger) on the leading edge 1072 of the grip 1052 and/orthe pull surfaces 1068, and a digit (for example, a finger or thumb) onthe trailing edge 1044 of the first wing 1040 and/or the trailing edge1044 of the second wing 1042. The clinician may then pull one or both ofthe leading edges 1072 proximally, and may push the trailing edge 1044and/or the pull surfaces 1068 distally. This may cause the cathetercomponent 1002 to remain in place while the needle component 1004 iswithdrawn proximally from the catheter component 1002.

FIG. 11 is a flowchart diagram depicting one method of preparing an IVcatheter system to deliver fluid to a patient, according to oneembodiment. The method of FIG. 11 may be carried out with any of the IVcatheter systems disclosed in FIGS. 1 through 10C, or with other IVcatheter system embodiments that are not specifically shown or describedherein. By way of example, the method will be described in connectionwith the IV catheter system 100 of FIG. 1. Further, the method of FIG.11 is merely exemplary; other methods may be used in conjunction withany of the IV catheter system embodiments included within the scope ofthe present disclosure.

The method may start 1110 with a step 1120 in which the catheter systemis prepared. This preparation may include connecting various components(such as the catheter component 102, the needle component 104, theextension tube 106, the clamp 108, and/or the luer lock adapter 110 ofFIG. 1, by way of example) together. Further, this may include preparingany adhesives needed to secure the catheter component 102 to thepatient, preparing components of the fluid source to be connected to theIV catheter system 100, and/or the like.

In a step 1130, the IV catheter system 100 may be grasped with a singlehand. This may involve placing digits of the hand to contact the pullsurface(s) of the needle component 104 and the push surface(s) of thecatheter component 102, as described above. Notably, the surfaces thatserve as pull surfaces and push surfaces may vary, depending on thespecific embodiment utilized. Further, catheter insertion may involveprimarily pushing; accordingly, the clinician may elect not to makecontact with the pull surfaces at this stage, but to contact them whenthe IV catheter system 100 is to be moved to the fluid deliveryconfiguration.

In a step 1140, the IV catheter system 100 may be manipulated to insertthe cannula 126 into the patient. This may optionally be done with asingle hand. Insertion may continue until the tip of the cannula 126 hasreached the fluid delivery location. Insertion may be carried out bypushing on the push surfaces and/or other surfaces of the cathetercomponent 102 and/or the needle component 104.

In a step 1150, the IV catheter system 100 may be moved from theinsertion configuration to the fluid delivery configuration. If theclinician has not yet contacted the pull surface(s) of the needlecomponent 104, he or she may do this now with one or more digits of ahand. Optionally, the same hand used to insert the IV catheter system100 may be used, exclusively (i.e., without assistance from the otherhand) to move the IV catheter system 100 to the fluid deliveryconfiguration. The clinician may pull the pull surface(s) proximally,while pushing on the push surface(s) to keep the catheter component 102in place. Thus, the catheter component 102 may be kept in place with thetip of the cannula 126 at the fluid delivery location while the needlecomponent 104 is withdrawn proximally from the catheter component 102 tounblock the fluid delivery path to the fluid delivery location.

This may optionally be accomplished with a single hand. Thus, the otherhand may be used to perform other tasks during insertion and/or motionof the IV catheter system 100 to the fluid delivery configuration. Forexample, the clinician may use the other hand to hold the patient's arm(or other body part in which the fluid delivery location is located),prepare other components for interconnection with the IV catheter system100, prepare any necessary blood testing materials, and/or the like.

The method may then end 1190. With the IV catheter system 100 in thefluid delivery configuration, the fluid source may then be connected tothe catheter component 102 to deliver the fluid to the patient.

An IV catheter system may have a wide variety of alternativeconfigurations within the scope of the present disclosure. Supplementalembodiments will be shown and described in brief, with reference toFIGS. 12A through 15D.

FIGS. 12A and 12B are perspective views of an IV catheter system 1200according to yet another alternative embodiment, in a fully-assembledstate and in an exploded state, respectively. The IV catheter system1200 may have components similar to those of the IV catheter systems ofprevious embodiments. FIG. 12A illustrates a catheter component 1202, aneedle component 1204, extension tubing 1206, a clamp 1208, and a luerlock adapter 1210. Only the catheter component 1202, the needlecomponent 1204, and the extension tubing 1206 are illustrated in FIG.12B. The IV catheter system 1200 may be an integrated system, as in someof the previous embodiments; hence, the extension tubing 1206 may bepre-attached to the catheter component 1202. Several components of theIV catheter system 1200 may be similar to those of previous embodimentsand thus will not be described explicitly; rather, understanding of theconfiguration and operation of these components can be obtained byreferring to the descriptions of previously described drawings.

As shown, the catheter component 1202 may have a securement platform1222 with a first wing 1240 and a second wing 1242. The first wing 1240may be integrated with an extension tubing junction 1224 that connectsthe extension tubing 1206 to the catheter component 1202. The secondwing 1242 may overlie a grip 1252 of the needle component 1204 in theinsertion configuration such that the distal ends of the grip 1242 andthe second wing 1242 have substantially the same, generally ellipticalshape.

The securement platform 1222 may optionally be “soft,” i.e., formed of arelatively compliant material that conforms easily to the skin of thepatient. In some embodiments, the securement platform 1222 may be formedof a soft plastic, an elastomer such as silicone rubber, and/or thelike. The securement platform 1222 and the grip 1252 may have one ormore grip features 1270 that facilitate gripping and/or manipulation ofthe securement platform 1222 and/or the grip 1252 by hand.

Further, the securement platform 1222 and/or the grip 1252 mayoptionally have features that further facilitate motion of the IVcatheter system 1200 from the insertion configuration to the fluiddelivery configuration. Specifically, the second wing 1242 may have adistal ridge 1280 that may act as a push feature. The distal ridge 1280may be positioned so that a digit can easily contact the proximal sideof the distal ridge 1280 to apply distal pressure on the second wing1242. The grip 1252 may have a peripheral ridge 1282 positioned at anexterior edge of the grip 1252. The peripheral ridge 1282 may act as apull feature. The peripheral ridge 1282 may be positioned such that adigit can easily contact the apex and/or the distal side of theperipheral ridge 1282 to apply proximal pressure on the grip 1252. Theperipheral ridge 1282 may optionally be positioned just outward of theoutermost edge of the second wing 1242 when the IV catheter system 1200is in the insertion configuration, so that the peripheral ridge 1282 canbe contacted by the digit even when the second wing 1242 is positionedto overlie the grip 1252.

Additionally or alternatively, the securement platform 1222 and/or thegrip 1252 may have one or more friction reducing features thatfacilitate motion from the insertion configuration to the fluid deliveryconfiguration. Such friction reducing features may optionally reduce thelevel of friction between the grip 1252 and the second wing 1242 so thatthe grip 1252 and the second wing 1242 can more easily slide past eachother. One such friction reducing feature may be a central ridge 1284 onthe second wing 1242, which may protrude toward the grip 1252. Thecentral ridge 1284 may abut the grip 1252 in the insertion configurationto reduce the surface area of the second wing 1242 that is in contactwith the grip 1252, thereby reducing frictional resistance to slidingmotion between the grip 1252 and the second wing 1242. The central ridge1284 may thus reduce the force required to move the IV catheter system1200 from the insertion configuration to the fluid deliveryconfiguration, thereby making this transition easier to accomplish withonly a single hand.

FIGS. 13A and 13B are perspective views of an IV catheter system 1300according to yet another alternative embodiment, in an open state and acompacted state, respectively. The clinician may have the flexibility toinsert and/or move the IV catheter system to the fluid deliveryconfiguration in the open state or in the compacted state. One or bothstates may facilitate manipulation of the IV catheter system 1300 withthe digits of a single hand. The IV catheter system 1300 may havecomponents similar to those of the IV catheter systems of previousembodiments. FIGS. 13A and 13B illustrate a catheter component 1302, aneedle component 1304, and extension tubing 1306. The IV catheter system1300 may be an integrated system, as in some of the previousembodiments; hence, the extension tubing 1306 may be pre-attached to thecatheter component 1302. Several components of the IV catheter system1300 may be similar to those of previous embodiments and thus will notbe described explicitly; rather, understanding of the configuration andoperation of these components can be obtained by referring to thedescriptions of previously described drawings.

As shown, the catheter component 1302 may have a securement platform1322 with a first wing 1340 and no second wing. The first wing 1340 maybe integrated with an extension tubing junction 1324 that connects theextension tubing 1306 to the catheter component 1302. In the compactedstate shown in FIG. 13B, the first wing 1340 may overlie a grip 1352 ofthe needle component 1304 such that the distal ends of the grip 1352 andthe first wing 1340 have substantially the same, generally ellipticalshape. In the open state of FIG. 13A, the first wing 1340 and the grip1352 may extend in generally opposite directions, providing a generallysymmetrical profile.

The securement platform 1322 may optionally be “soft,” i.e., formed of arelatively compliant material that conforms easily to the skin of thepatient. In some embodiments, the securement platform 1322 may be formedof a soft plastic, an elastomer such as silicone rubber, and/or thelike. The securement platform 1322 and the grip 1352 may have one ormore grip features 1370 that facilitate gripping and/or manipulation ofthe securement platform 1322 and/or the grip 1352 by hand.

Further, the securement platform 1322 and/or the grip 1352 may have oneor more friction reducing features that facilitate motion from theinsertion configuration to the fluid delivery configuration. Suchfriction reducing features may optionally reduce the level of frictionbetween the grip 1352 and the first wing 1340 so that the grip 1252 andthe first wing 1340 can more easily slide past each other in thecompacted state. One such friction reducing feature may be a centralridge 1384 on the grip 1352, which may protrude toward the first wing1340 in the compacted state. The central ridge 1384 may abut the firstwing 1340 in the insertion configuration, in the compacted state toreduce the surface area of the grip 1352 that is in contact with thefirst wing 1340, thereby reducing frictional resistance to slidingmotion between the grip 1352 and the first wing 1340. The central ridge1384 may thus reduce the force required to move the IV catheter system1300 from the insertion configuration to the fluid deliveryconfiguration, thereby making this transition easier to accomplish withonly a single hand when in the closed configuration.

FIGS. 14A, 14B, 14C, and 14D are perspective views of an IV cathetersystem 1400 according to yet another alternative embodiment, in theinsertion configuration in a compacted state, with the cathetercomponent 1402 in isolation, in the insertion configuration in an openstate, and with the flash component 1412 in an exploded state,respectively. The IV catheter system 1400 may have components similar tothose of the IV catheter systems of previous embodiments. FIG. 14Aillustrates a catheter component 1402, a needle component 1404,extension tubing 1406, and a flash component 1412. The IV cathetersystem 1400 may be an integrated system, as in some of the previousembodiments; hence, the extension tubing 1406 may be pre-attached to thecatheter component 1402. Several components of the IV catheter system1400 may be similar to those of previous embodiments and thus will notbe described explicitly; rather, understanding of the configuration andoperation of these components can be obtained by referring to thedescriptions of previously described drawings.

As shown, the catheter component 1402 may have a securement platform1422 with a first wing 1440 and a second wing 1442. The first wing 1440may be integrated with an extension tubing junction 1424 that connectsthe extension tubing 1406 to the catheter component 1402. The secondwing 1442 may overlie a grip 1452 of the needle component 1404 in theinsertion configuration such that the distal ends of the grip 1442 andthe second wing 1442 have substantially the same, generally ellipticalshape, except that the grip 1452 may be slightly larger than the secondwing 1442. Thus, the grip 1452 may extend beyond the profile of thesecond wing 1442.

The securement platform 1422 may optionally be “soft,” i.e., formed of arelatively compliant material that conforms easily to the skin of thepatient. In some embodiments, the securement platform 1422 may be formedof a soft plastic, an elastomer such as silicone rubber, and/or thelike. The securement platform 1422 and the grip 1452 may have one ormore grip features 1470 that facilitate gripping and/or manipulation ofthe securement platform 1422 and/or the grip 1452 by hand.

Further, the securement platform 1422 and/or the grip 1452 mayoptionally have features that further facilitate motion of the IVcatheter system 1400 from the insertion configuration to the fluiddelivery configuration. Specifically, the extension tubing junction 1424may have a depression 1480 that may act as a push feature. Thedepression 1480 may be positioned so that a digit can easily contact theextension tubing junction 1424, and thence the first wing 1440, to applydistal pressure on the first wing 1440. The second wing 1442 may havestepdown 1482 at which the second wing 1442 moves from a greaterthickness toward the distal end of the second wing 1442 to a lesserthickness toward the proximal end of the second 1442. The stepdown 1482may thus provide a proximally-oriented surface that can also act as apush feature. The clinician may place a digit on the proximally-orientedsurface of the second wing 1442 to facilitate exertion of distalpressure on the second wing 1442.

The grip 1452 may have a proximal ridge 1483 positioned at a proximaledge of the grip 1452. The proximal ridge 1483 may act as a pullfeature. The proximal ridge 1483 may be positioned such that a digit caneasily contact the apex and/or the distal side of the proximal ridge1483 to apply proximal pressure on the grip 1452. The proximal ridge1483 may optionally be positioned just proximally of the proximal edgeof the second wing 1442 when the IV catheter system 1400 is in theinsertion configuration, so that the proximal ridge 1483 can becontacted by the digit even when the second wing 1442 is positioned tooverlie the grip 1452.

Additionally or alternatively, the securement platform 1422 and/or thegrip 1452 may have one or more friction reducing features thatfacilitate motion from the insertion configuration to the fluid deliveryconfiguration. Such friction reducing features may optionally reduce thelevel of friction between the grip 1452 and the second wing 1442 so thatthe grip 1452 and the second wing 1442 can more easily slide past eachother. One such friction reducing feature may be a series of centralbumps 1484 on the grip 1452, which may protrude toward the second wing1442. The central bumps 1484 may abut the second wing 1442 in theinsertion configuration to reduce the surface area of the second wing1442 that is in contact with the grip 1452, thereby reducing frictionalresistance to sliding motion between the grip 1452 and the second wing1442. The central bumps 1484 may thus reduce the force required to movethe IV catheter system 1400 from the insertion configuration to thefluid delivery configuration, thereby making this transition easier toaccomplish with only a single hand.

As shown in FIG. 14C, the central bumps 1484 may optionally be alignedwith a central trough 1485 formed in the surface of the second wing 1442that faces the grip 1452. The central trough 1485 may receive thecentral bumps 1484. Thus, the central bumps 1484 and the central trough1485 may act as alignment features to maintain alignment between thesecond wing 1442 and the grip 1452, thereby reducing the likelihood ofbinding or other resistance to motion to the fluid deliveryconfiguration that could otherwise be caused by misalignment between thecatheter component 1402 and the needle component 1404.

FIG. 14C illustrates an open state in which the needle component 1404 isrotated relative to the catheter component 1402 in a manner thatpositions the grip 1452 substantially perpendicular to the securementplatform 1422. In this state, the IV catheter system 1400 may providealternative ergonomics for inserting the cannula into the fluid deliverylocation and/or moving the IV catheter system 1400 to the fluid deliveryconfiguration. In this state, the central bumps 1484 may not bepositioned within the central trough 1485. However, when the needlecomponent 1404 and catheter component 1402 are again rotated relative toeach other to position the IV catheter system 1400 in the compactedstate, the central bumps 1484 may enter the central trough 1485 toensure proper alignment between the needle component 1404 is rotatedrelative to the catheter component 1402.

The flash component 1412 may indicate proper placement of the cannula ofthe catheter component 1402. When the cannula penetrates a blood vessel,the resulting blood flow may pass into the catheter component 1402 andthrough the needle component 1404 to reach the flash component 1412,which may be secured to the proximal end of the needle component 1404.The blood may enter a flash chamber 1414 of the flash component 1412,which may be visible to the user through transparent walls of the flashcomponent 1412. The flash component 1412 may also have a vent 1416 thatpermits egress of any air in the IV catheter system 1400 as the bloodenters, to ensure that the blood is able to fill the flash component1412.

FIGS. 15A, 15B, 15C, and 15D are perspective views of an IV cathetersystem 1500 according to yet another alternative embodiment, in theinsertion configuration in a compacted state, with the cathetercomponent 1502 and needle component 1504 in isolation, in the insertionconfiguration in an open state, and with the flash component 1512 in anexploded state, respectively. The IV catheter system 1500 may havecomponents similar to those of the IV catheter systems of previousembodiments. FIG. 15A illustrates a catheter component 1502, a needlecomponent 1504, extension tubing 1506, and a flash component 1512. TheIV catheter system 1500 may be an integrated system, as in some of theprevious embodiments; hence, the extension tubing 1506 may bepre-attached to the catheter component 1502. Several components of theIV catheter system 1500 may be similar to those of previous embodimentsand thus will not be described explicitly; rather, understanding of theconfiguration and operation of these components can be obtained byreferring to the descriptions of previously described drawings.

As shown, the catheter component 1502 may have a securement platform1522 with a first wing 1540 and a second wing 1542. The first wing 1540may be integrated with an extension tubing junction 1524 that connectsthe extension tubing 1506 to the catheter component 1502. The secondwing 1542 may overlie a grip 1552 of the needle component 1504 in theinsertion configuration such that the distal ends of the grip 1542 andthe second wing 1542 have substantially the same, generally ellipticalshape, except that the grip 1552 may be slightly larger than the secondwing 1542. Thus, the grip 1552 may extend beyond the profile of thesecond wing 1542.

The securement platform 1522 may optionally be “soft,” i.e., formed of arelatively compliant material that conforms easily to the skin of thepatient. In some embodiments, the securement platform 1522 may be formedof a soft plastic, an elastomer such as silicone rubber, and/or thelike. The securement platform 1522 and the grip 1552 may have one ormore grip features 1570 that facilitate gripping and/or manipulation ofthe securement platform 1522 and/or the grip 1552 by hand.

Further, the securement platform 1522 and/or the grip 1552 mayoptionally have features that further facilitate motion of the IVcatheter system 1500 from the insertion configuration to the fluiddelivery configuration. Specifically, the extension tubing junction 1524may have a depression 1580 that may act as a push feature. Thedepression 1580 may be positioned so that a digit can easily contact theextension tubing junction 1524, and thence the first wing 1540, to applydistal pressure on the first wing 1540. The second wing 1542 may havestepdown 1582 at which the second wing 1542 moves from a greaterthickness toward the distal end of the second wing 1542 to a lesserthickness toward the proximal end of the second 1542. The stepdown 1582may thus provide a proximally-oriented surface that can also act as apush feature. The clinician may place a digit on the proximally-orientedsurface of the second wing 1542 to facilitate exertion of distalpressure on the second wing 1542. A stepdown ridge 1588 may bepositioned proximate the stepdown 1582 to broaden the size of theproximally-facing surface provided by the stepdown 1582, therebyfacilitating use of the stepdown 1582 as a push feature.

The grip 1552 may have a peripheral ridge 1583 positioned at an outeredge of the grip 1552. The peripheral ridge 1583 may act as a pullfeature. The peripheral ridge 1583 may be positioned such that a digitcan easily contact the apex and/or the distal side of the peripheralridge 1583 to apply proximal pressure on the grip 1552. The peripheralridge 1583 may optionally be positioned outward of the outer edge of thesecond wing 1542 when the IV catheter system 1500 is in the insertionconfiguration, so that the peripheral ridge 1583 can be contacted by thedigit even when the second wing 1542 is positioned to overlie the grip1552. The peripheral ridge 1583 may define the boundary of a distalrecess 1586 of the grip 1552 within which the second wing 1542 canreside in the insertion configuration.

Further, the grip 1552 may have a proximal recess 1584. The upraisededges of the grip 1552 that surround and define the proximal recess 1584may also act as pull features. The clinician may place the digit of ahand on any of these edges to exert proximal pressure on the grip 1552.

Additionally or alternatively, the securement platform 1522 and/or thegrip 1552 may have one or more friction reducing features thatfacilitate motion from the insertion configuration to the fluid deliveryconfiguration. Such friction reducing features may optionally reduce thelevel of friction between the grip 1552 and the second wing 1542 so thatthe grip 1552 and the second wing 1542 can more easily slide past eachother. One such friction reducing feature may be a central ridge 1592 onthe second wing 1542, which may protrude toward the grip 1552. Thecentral ridge 1592 may abut the grip 1552 in the insertion configurationto reduce the surface area of the second wing 1542 that is in contactwith the grip 1552, thereby reducing frictional resistance to slidingmotion between the grip 1552 and the second wing 1542. The central ridge1592 may thus reduce the force required to move the IV catheter system1500 from the insertion configuration to the fluid deliveryconfiguration, thereby making this transition easier to accomplish withonly a single hand.

As shown in FIG. 15C, the central ridge 1590 may optionally be alignedwith a central trough 1592 formed in the surface of the grip 1552 thatfaces the second wing 1542. The central trough 1592 may receive thecentral ridge 1590. Thus, the central ridge 1590 and the central trough1592 may act as alignment features to maintain alignment between thesecond wing 1542 and the grip 1552, thereby reducing the likelihood ofbinding or other resistance to motion to the fluid deliveryconfiguration that could otherwise be caused by misalignment between thecatheter component 1502 and the needle component 1504.

FIG. 15C illustrates an open state in which the needle component 1504 isrotated relative to the catheter component 1502 in a manner thatpositions the grip 1552 substantially perpendicular to the securementplatform 1522. In this state, the IV catheter system 1500 may providealternative ergonomics for inserting the cannula into the fluid deliverylocation and/or moving the IV catheter system 1500 to the fluid deliveryconfiguration. In this state, the central ridge 1590 may not bepositioned within the central trough 1592. However, when the needlecomponent 1504 and catheter component 1502 are again rotated relative toeach other to position the IV catheter system 1500 in the compactedstate, the central ridge 1590 may enter the central trough 1592 toensure proper alignment between the needle component 1504 is rotatedrelative to the catheter component 1502.

The flash component 1512 may indicate proper placement of the cannula ofthe catheter component 1502. When the cannula penetrates a blood vessel,the resulting blood flow may pass into the catheter component 1502 andthrough the needle component 1504 to reach the flash component 1512,which may be secured to the proximal end of the needle component 1504.The blood may enter a flash chamber 1514 of the flash component 1512,which may be visible to the user through transparent walls of the flashcomponent 1512.

Various embodiments of the present invention (not shown) furthercomprise a safety mechanism configured to secure the sharpened, distaltip of the introducer needle following removal and separation of theneedle component from the catheter component. A safety mechanism mayinclude any compatible device known in the art. In some instances, thesafety mechanism is configured to interact with a needle feature, suchas a ferrule, notch, crimp or bump on the needle. The crimp or bumpformed in the needle cause a slight out of round configuration that canbe used to activate a safety mechanism. In some instance, the safetymechanism comprises an arm or lever that is actuated to capture theneedle tip within the mechanism and prevent the tip from emerging priorto safe disposal.

The safety mechanism is attached to the body of the needle and iscapable of sliding along the length thereof. In some instances, aninitial or assembled position of the safety mechanism is located inproximity to the base or proximal end of the needle component prior tocatheterization. For some configurations, the assembled position of thesafety mechanism is between the proximal end of the needle hub and theproximal end of the catheter hub or securement platform, wherein thesafety mechanism does not overlap the catheter hub or securementplatform. In some instances, a portion of the safety mechanism ispositioned within the catheter hub, with the balance of the safetymechanism being positioned external to the catheter hub, such as withinthe needle hub. In some embodiments, a portion of the catheter hub orsecurement platform is extended proximally to provide a housing in whichat least a portion of the safety mechanism is housed. In some instances,the entire safety mechanism is housed within the housing of the catheterhub or securement platform prior to catheterization.

In some embodiments, the assembled position of the safety mechanismpositions the proximal end of the catheter hub between the distal end ofthe safety mechanism and a distal end of a grip of the needle component.In some instances, the assembled position of the safety mechanismpositions the proximal end of the catheter hub between the distal end ofthe safety mechanism and a proximal end of a grip of the needlecomponent. In some instances, a portion of the safety mechanism overlapsa portion of a grip of the needle component. In some embodiments, atleast some portion of at least one of the catheter hub and the gripoverlaps at least some portion of the safety mechanism. In someembodiments, no portion of the catheter hub or grip overlaps any portionof the safety mechanism.

In some embodiments, a defeatable mechanical connection is providedbetween the safety mechanism and at least one other component of the IVcatheter system. In some embodiments, a distal end of the safetymechanism is selectively coupled to a proximal end of the catheter hub.In one embodiment, the safety mechanism interlocks internally to theproximal end of the catheter hub. In one embodiment, the safetymechanism interlocks externally to the proximal end of the catheter hub.In some embodiments, a distal end of the safety mechanism is selectivelycoupled to a proximal end of the securement platform. In someembodiments, a surface of the safety mechanism is selectively coupled toat least one surface of at least one of the catheter hub, a bloodcontrol valve, an extension tube, and the securement platform. In someinstances, the mechanical connection is defeated upon securement of theneedle tip within the safety mechanism.

FIGS. 16, 17, 18A, 18B, 19A, and 19B depict various modifications thatcan be made to many of the IV catheter systems described above. Forillustrative purposes, these modifications will be described withreference to IV catheter system 1400 shown in FIGS. 14A and 14B.However, these modifications could equally be made to other IV cathetersystems described herein.

FIG. 16 illustrates an IV catheter system 1600 that is configured in thesame manner as IV catheter system 1400 except that first wing 1440 onlyextends between catheter component 1402 and extension tubing junction1424. In other words, in FIG. 16, first wing 1440 does not extendoutwardly beyond extension tubing junction 1424. In such embodiments,first wing 1440 may extend between catheter component 1402 and extensiontubing junction 1424 to provide reinforcement to extension tubingjunction 1424 thereby facilitating the use of extension tubing junction1424 as a gripping surface during insertion. As indicated above, in manyof the other embodiments described, the portion of the first wing thatextends beyond the extension tubing junction could also be removed.

FIG. 17 illustrates an IV catheter system 1700 that is configured in thesame manner as IV catheter system 1400 except that flash component 1412includes a side vent. In particular, as shown in FIG. 17, flashcomponent 1412 can include a proximal vent 1416 a as is described above(and labeled 1416 in FIG. 14). Additionally, flash component 1412 caninclude one or more side vents 1416 b that are formed through thesidewall of flash component 1412. These side vents can be positionedproximal to a vent membrane 1701 and provide an alternative oradditional venting pathway for air as it exits flash chamber 1412.

When some clinicians insert an IV, they may place their thumb overtopproximal vent 1416 a thereby blocking airflow through the vent andminimizing the flow of blood into flash component 1412. Therefore, IVcatheter system 1700 can include side vents 1416 b which will provide analternative pathway for airflow in instances where proximal vent 1416 amay be blocked. Side vents 1416 b can be shaped in any suitable manner.In some embodiments, flash component 1412 could be elongated toaccommodate appropriately-sized side vents. Any of the otherabove-described IV catheter systems that also employ a flash componentmay also be configured with side vents. In some embodiments, a portionof proximal vent 1416 a extends onto the sidewall of flash component1412 to form side vent 1416 b. Thus, the user's thumb may block theportion of proximal vent 1416 a located on the proximal end of flashcomponent 1412 without contacting or blocking the portion of theproximal vent located on, and thereby forming side vent 1416 b.

FIGS. 18A and 18B illustrate perspective and side views respectively ofan IV catheter system 1800 that is configured in the same manner as IVcatheter system 1400 except that catheter component 1402 includes avisual indicator 1801 at a proximal end. Visual indicator 1801 ispositioned on catheter component 1402 so that it will be covered byneedle component 1404 prior to insertion of the catheter. During theinsertion process, needle component 1404 can be slightly withdrawn withrespect to catheter component 1402 which would result in the tip of theneedle being withdrawn into, or “hooded” within the catheter. Therelative positions of catheter component 1402 and needle component 1404when the needle is in this hooded position are depicted in FIG. 18A.

Once a clinician has inserted the needle into a patient's vein, theclinician will oftentimes withdraw the needle tip into the hoodedposition before further inserting the catheter. Catheter component 1402can include visual indicator 1801 as a means of informing the clinicianwhen the needle tip is in the hooded position. In other words, duringthe initial insertion process, needle component 1404 will be positionedovertop visual indicator 1801 (e.g., similar to what is shown in FIG.14A). Then, as the clinician slides needle component 1404 backwards awayfrom catheter component 1402, visual indicator 1801 will be revealed asshown in FIG. 18A thereby informing the clinician when the needle tiphas reached the hooded position.

In some instances, visual indicator 1801 is located on cathetercomponent 1402 at a position selected to reveal visual indicator 1801when catheter component 1402 has been removed or withdrawn from theneedle adapter a desired distance. For example, in some embodiments theneedle tip is hooded within the catheter when catheter component 1402 isremoved from the needle adapter a distance of 2 mm. Accordingly, in someembodiments visual indicator 1801 is positioned within the needleadapter at a distance of approximately 2 mm when catheter component 1402is fully seated within the distal end or opening of the needle adapter.

FIG. 18B provides a side view of catheter component 1402 of IV cathetersystem 1800 in isolation. As shown, visual indicator 1801 is positionednear a proximal end of catheter component 1402. As indicated above, theexact position of visual indicator 1801 will be dependent on how needlecomponent 1404 and catheter component 1402 overlap. In particular,visual indicator 1801 can be positioned so that it becomes exposed oncethe needle tip reaches the hooded position but prior to needle component1404 decoupling from catheter component 1402. In some instances, theexposure occurs after a translational movement of approximately 2 mm. Inthis way, the clinician can easily separate needle component 1404 fromcatheter component 1402 to reach the hooded position while stillmaintaining sufficient coupling between the two components to facilitatefurther insertion of the catheter.

A visual indicator similar to visual indicator 1801 could be added toany of the above-described IV catheter systems to provide the indicationof when the needle has reached the hooded position. Also, in someembodiments, a tactile indicator in place of or in addition to a visualindicator could be employed. For example, needle component 1404 and/orcatheter component 1402 may include one or more features (e.g., ridgesor grooves) that provide a tactile indication of when the needle hasreached the hooded position.

FIGS. 19A and 19B illustrate perspective and side views respectively ofan IV catheter system 1900 that is configured in a similar manner as IVcatheter system 1400 except that catheter component 1402 and needlecomponent 1404 are configured to facilitate various types of insertiongrip techniques. As shown in FIG. 19A, flash component 1412 is elongatedin comparison to the flash component depicted in FIG. 14A. Additionally,flash component 1412 includes side grips 1902 which constitute featuresformed on opposing sides of flash component 1412 which facilitategripping flash component 1412 between the thumb and middle finger. Forexample, side grips 1902 can comprise flattened surfaces and/or othertypes of gripping features such as ridges.

As best seen in FIG. 19B, catheter component 1402 may include a push tab1901 which extends upwardly from a top surface of catheter component1402. Push tab 1901 can serve as a surface against which the clinician'sindex finger may push while gripping side grips 1902 between the thumband middle finger. The length of flash component 1412 can be configuredso that push tab 1901 is spaced from side grips 1902 at a distancecorresponding to the average length of a clinician's index finger. Theadditional length of flash component 1412 can also allow flash to bevisualized for a longer period of time. Other IV catheter systemsdescribed herein that incorporate a flash component into the needlecomponent may also be configured to include side grips and a push tab ina similar manner as shown in FIGS. 19A and 19B.

FIG. 20 illustrates an IV catheter system 2000 that is configured in asimilar manner as IV catheter system 1400 but with a number ofadditional features. As with IV catheter system 1400, IV catheter system2000 includes a catheter component having a securement platform 1422,extension tubing, and a needle component incorporating a flash component1412. As shown in FIG. 20, IV catheter system 2000 also includes a softintegral push tab 2001, a push tab cut-out 2002, and an integratedstrain relief 2003.

Push tab 2001 can be integrally molded from the same material assecurement platform 1422. For example, push tab 2001 can include a base2001 a that is positioned on top of and towards the proximal end of thecatheter adapter. Base 2001 a may be connected to securement platform1422 by connecting channels 2001 b which extend downwardly from base2001 a on both sides of the catheter adapter. Connecting channels 2001 bcan reinforce base 2001 a and can facilitate the molding process. Anumber of ridges 2001 c may extend upwardly from base 2001 a and canfunction as a surface against which a clinician may push while insertingthe needle and/or when separating the needle component from the cathetercomponent, such as when hooding the needle during catheterization. Insome embodiments, textures and/or indents may be employed in place of orin conjunction with ridges 2001 c.

Cut-out 2002 can be formed in a top surface of the distal end of theneedle component such that cut-out 2002 will substantially align withbase 2001 a. Cut-out 2002 therefore creates a region in which theclinician can place his or her finger or thumb to more easily apply adistal force against push tab 2001.

Strain relief 2003 can also be integrally molded from the same materialas securement platform 1422. To facilitate molding strain relief 2003, aconnecting channel 2003 a can be formed between securement platform 1422and strain relief 2003.

Although push tab 2001 and strain relief 2003 are shown as includingconnecting channels, each of these features could equally be moldedseparately from securement platform 1422 (i.e., molded withoutconnecting channels) in some embodiments. Also, each of push tab 2001,cut-out 2002, and strain relief 2003 could be included on any of theother IV catheter systems described herein.

In some embodiments, IV catheter system 2000 may include ananti-rotation feature. For example, as shown in FIG. 21, thisanti-rotation feature can be comprised of a protrusion 2010 formed at aproximal end of the catheter component and a corresponding protrusion2011 formed within the portion of needle component into which thecatheter component inserts. Protrusions 2010 and 2011 can be positionedrelative to one another to prevent the wing from being rotateddownwardly away from the securement platform.

For example, with reference to the orientation shown in FIG. 21,protrusion 2011 may be configured to contact protrusion 2010 when thewing is oriented directly below the securement platform so that the wingcannot be further rotated in a counterclockwise direction relative tothe catheter component. In this way, the wing can be prevented fromsagging downward. At the same time, however, the wing will still be ableto rotate in a clockwise direction to easily accommodate different griptechniques. This anti-rotation feature could also be included in any ofthe other embodiments of IV catheter systems described herein.

To this point, each of the described IV catheter systems has been aclosed system (i.e., a system that includes extension tubing). It isnoted, however, that many of the above described features can equally beimplemented on an open IV catheter system (i.e., a system that does notinclude extension tubing). FIGS. 22A and 22B illustrate an example of anopen IV catheter system 2200 that is otherwise substantially the same asIV catheter system 2000. As shown, IV catheter system 2200 includes acatheter component 1402 a that does not incorporate extension tubing.Because it is an open system, catheter component 1402 a can beconfigured to provide intravascular access once the needle component hasbeen removed. For example, catheter component 1402 a can include aninternal, blood control feature, whether single use or multi-use (notshown), and a threaded luer connection 2202 to thereby allow otherdevices to be coupled to the catheter component. Alternatively, cathetercomponent 1402 a may not include a blood control feature.

IV catheter system 2200 is shown as including a flash chamber 1412 thatincludes a path-defining structure 2800. Any of the above described IVcatheter systems, whether open or closed, can employ a path-definingstructure 2800 within the flash chamber to enhance the visualization ofproper catheter placement. More particularly, a path-defining structurecan cause blood to flow through the flash chamber at a more controlledrate that facilitates identifying when the catheter is properlypositioned within the vasculature.

FIG. 23 illustrates path-defining structure 2800 in isolation.Path-defining structure 2800 includes a distal portion 2800 a and aproximal portion 2800 b. In some embodiments, proximal portion 2800 bcan have an outer dimension that substantially matches an innerdimension of a proximal end of flash component 1412 such that afluid-tight seal is formed between the two components. Proximal portion2800 b can include venting grooves 2802 which are sized to allow air,but not fluid, to escape from within flash component 1412. In otherwords, proximal portion 2800 b can function as a vent plug.

Distal portion 2800 a can have a reduced outer dimension compared to theouter dimension of proximal portion 2800 b. The inner dimension of achamber 3210 b of flash component 1412 (see FIG. 24A) with respect tothe outer dimension of distal portion 2800 a can also be configured suchthat a spacing or channel will exist between distal portion 2800 a andthe inner wall of chamber 3210 b only along the top of flash component1412. For example, as shown in FIG. 24A, with path-defining structure2800 inserted into chamber 3210 b, a channel will exist abovepath-defining structure 2800. However, around the remaining portions ofpath-defining structure 2800, the outer surface of distal portion 2800 acan contact the inner wall of chamber 3210 b. In this way, blood/fluidwill only be allowed to flow along the outer surface of distal portion2800 a within the channel. Since this channel is formed along the top offlash component 1412, which will be oriented towards the clinicianduring insertion, the clinician will be able to visualize the rate ofblood flow.

To allow blood to flow from the proximal end of needle 3202 a into thischannel, an opening 2801 can be formed in a distal end 2800 a 1 ofdistal portion 2800 a as is best shown in FIG. 24A. Opening 2801 caninclude a central portion 2801 a that extends further into distalportion 2800 a then the remainder of opening 2801. The proximal end (orat least a proximal opening) of needle 3202 a can be positioned withinthis central portion 2801 a. A number of leaking channels 2801 a 1 canbe symmetrically spaced around an inner surface of opening 2801 and canextend from distal end 2800 a 1 to central portion 2801 a. Any ofleaking channels 2801 a 1 can serve as a fluid pathway by which bloodescaping the proximal end of needle 3202 a can flow from central portion2801 a towards the channel formed above path-defining structure 2800.

Leaking channels 2801 a 1 can be symmetrically spaced around opening2801 to thereby allow path-defining structure 2800 to be inserted intochamber 3210 b in any orientation. In other words, regardless of theorientation of path-defining structure 2800, at least one leakingchannel 2801 a 1 will be positioned in an upward orientation and willintersect with the channel to thereby provide a pathway to the channel.As shown in FIG. 24A, the inner surface of chamber 3210 b can be shapedsuch that the channel will wrap around distal end 2800 a 1 at the top ofchamber 3210 b (i.e., a gap will exist between a top portion of distalend 2800 a 1 and the inner surface of chamber 3210 b). Accordingly, asrepresented by the arrow in FIG. 24B, blood can flow out of needle 3202a via opening 3202 a 1 and into central portion 2801 a. Then, althoughthe blood may flow into each of leaking channels 2801 a 1, a fluidpathway will only be provided between the leaking channel that isoriented upward due to distal end 2800 a 1 contacting the inner wall ofchamber 3210 b where the other leaking channels are positioned.Therefore, as the blood fills central portion 2801 a and leakingchannels 2801 a 1, it will ultimately flow around the top portion ofdistal end 2800 a 1 and then proximally within the channel.

To secure needle 3202 a and to ensure that opening 3202 a 1 remainspositioned within central portion 2801 a, various techniques can beemployed. For example, in FIG. 24C, needle 3202 a is shown as having aproximal portion 3202 a 2 that extends proximally beyond opening 3202 a1 and through a proximal wall of central portion 2801 a. In thisembodiment, path-defining structure 2800 includes a proximal chamber2810 opposite central portion 2801 a within which proximal portion 3202a 2 of needle 3202 a is positioned. Proximal portion 3202 a 2 can becurled or otherwise altered to prevent it from being pulled distallythrough the passageway between central portion 2801 a and proximalchamber 2810. Also, in some embodiments, adhesive potting may bedeposited within proximal chamber 2810 around proximal portion 3202 a 2to further secure proximal portion 3202 a 2. In such embodiments, theadhesive potting may additionally seal the passageway to prevent bloodfrom flowing into proximal chamber 2810. Alternatively, the passagewaymay be sized such that proximal portion 3202 a 2 alone blocks fluid flowinto proximal chamber 2810.

FIG. 24D illustrates an alternate embodiment for securing needle 3202 ain position. As shown, needle 3202 a may include a bumped area 3202 a 3that has an outer dimension sufficient to prevent needle 3202 a frombeing pulled through needle retaining portion 3202 c. Bumped area 3202 a3 can be positioned relative to opening 3202 a 1 so that opening 3202 a1 remains positioned within central portion 2801 a. In some embodiments,needle retaining portion 3202 c may include a recessed section intowhich bumped area 3202 a 3 can be positioned to further prevent area3202 a from moving in a proximal or distal direction.

In some embodiments, needle 3202 a may be modified to reduce the rate atwhich blood will flow through the needle. For example, in FIG. 24E,needle 3202 a is shown as having a crimp 3202 a 4 towards its proximalend. Crimp 3202 a 4 reduces the inside dimension of needle 3202 athereby slowing the rate at which blood will flow into central portion2801 a. Reducing the rate of blood flow into central portion 2801 a willlikewise reduce the rate of blood flow along the channel formed abovepath-defining structure 2800 thereby facilitating identifying whenneedle 3202 a has been properly positioned within the patient.

FIGS. 25A and 25B illustrate another embodiment of a path-definingstructure 2900 that can function in a similar manner as path-definingstructure 2800. In particular, path-defining structure 2900 can beconfigured to cause blood to flow along a visualization channel formedat the top of flash component 1412.

Path-defining structure 2900 can include a distal portion 2900 a and aproximal portion 2900 b. Proximal portion 2900 b can include ventinggrooves 2902 that function to vent air but not blood from a proximal endof flash component 1412. Unlike distal portion 2800 a of path-definingstructure 2800, distal portion 2900 a of path-defining structure 2900 isnot configured to be oriented at any position within flash component1412. Instead, distal portion 2900 a can include a visualization channel2903 and various alignment ribs 2904 that are configured for aparticular orientation. The inner surface of chamber 3210 b can beconfigured to accommodate alignment ribs 2904 in such a manner thatpath-defining structure 2900 will be oriented with visualization channel2903 facing upwards. For example, chamber 3210 b could includelengthwise grooves or tabs which interface with alignment ribs 2904 torequire insertion of path-defining structure 2900 in the correctorientation and to prevent rotation.

Distal portion 2900 a of path-defining structure 2900 can include adistal end 2900 a 1 having an opening 2901. A leaking channel 2901 a canextend between opening 2901 and visualization channel 2903. In a similarmanner as described above, blood can flow out of opening 3202 a 1 intoopening 2901 through leaking channel 2901 a and into visualizationchannel 2903 as represented by the arrows in FIG. 25C. Although notdepicted in this embodiment, the various configurations of needle 3202 ashown in FIGS. 24C-24E can also be employed in conjunction withpath-defining structure 2900.

FIG. 26 illustrates an embodiment of a flash component 1412 in which avent plug 3000 is employed in place of proximal portion 2900 b. Also,although not shown, vent plug 3000 could equally be employed in place ofproximal portion 2800 b. As depicted in FIG. 26, vent plug 3000 isseparate from and positioned proximally to path-defining structure 2900.Vent plug 3000 can primarily function to vent air but block fluid.However, in some embodiments, vent plug 3000 may also be configured tosecure path-defining structure 2800/2900 in place. For example, flashcomponent 1412 can include protrusions 3010 that are positionedproximally to vent plug 3000 when vent plug 3000 is inserted intochamber 3210 b. Protrusions 3010 can prevent vent plug 3000, andtherefore path-defining structure 2800/2900, from moving proximallywithin chamber 3210 b.

FIGS. 27A-27C each represent a different way in which path-definingstructure 2800 or 2900 could be secured within chamber 3210 b. In FIG.27A, opening 2901 is shown as having an inner dimension that correspondsclosely with the outer dimension of needle retaining portion 3202 c suchthat a press-fit interface is formed. Opening 2801 could equally beconfigured in this manner. Alternatively, opening 2801/2901 could bemolded overtop needle retaining portion 3202 c.

In FIGS. 27B and 27C, path-defining structure 2800/2900 can be retainedwithin chamber 3210 b using an interface between proximal portion 2800b/2900 b and an inner surface of chamber 3210 b. In FIG. 27B, chamber3210 b can include a sloped retention bump 3101. The slope of bump 3101can cause a distal facing ledge to be formed against which a proximalend of proximal portion 2800 b or 2900 b contacts. This slopingfacilitates inserting path-defining structure 2800 or 2900 but preventsit from being later withdrawn.

FIG. 27C illustrates an example where proximal portion 2800 b or 2900 bincludes a retention rib 3102 a which inserts into a retention trench3102 b formed on an inner surface of chamber 3210 b. During assembly,path-defining structure 2800 or 2900 can be inserted into chamber 3210 buntil retention rib 3102 a inserts into retention trench 3102 b. At thispoint, retention rib 3102 a will prevent the path-defining structurefrom being proximally withdrawn.

In some embodiments, a porous material could be employed within thechannel created by the path-defining structure. For example, in FIG.28A, a porous material 3200 can be fabricated into visualization channel2903 and extend through the portion of proximal portion 2900 b thatincludes venting grooves 2902. Porous material 3200 can function to ventair while also wicking the blood at a rate that will be easilyvisualized. Alternatively, porous material 3200 may only be positionedwithin the portion of proximal portion 2900 b as shown in FIG. 28B.

FIGS. 29 and 30 each depict additional variations that can be made toembodiments that employ either path-defining structure 2800 or 2900. InFIG. 29, opening 2901 is shown having a larger depth. With this largerdepth, more fluid volume will be required before blood will flow throughthe channel. Accordingly, the depth of opening 2801 or 2901 can beselected to generally control when visual feedback of proper veinconfirmation will be provided. In FIG. 30, a sealing cap 3400 ispositioned overtop the proximal opening of flash component 1412. Sealingcap 3400 can block the flow of air until removed. Therefore, sealing cap3400 can be employed in situations where an extension tube is pre-primedwith saline to prevent the saline from flowing proximally into flashcomponent 1412. More specifically, with sealing cap 3400 in place, thesaline will only be allowed to flow distally within needle 3202 a. Afterinsertion of the needle, sealing cap 3400 can be removed to allow flashcomponent 1412 to be employed in the manner described above.

Various embodiments of the present invention further comprise a safetymechanism configured to secure the sharpened, distal tip of theintroducer needle following removal and separation of the needle hubfrom the catheter adapter. A safety mechanism may include any compatibledevice known in the art. In some instances, the safety mechanism isconfigured to interact with a needle feature, such as a ferrule, notch,crimp or bump on the cannula. The crimp or bump formed in the cannulacauses a slight out of round configuration that can be used to activatea safety mechanism. In some instance, the safety mechanism comprises anarm or lever that is actuated to capture the needle tip within themechanism and prevent the tip from emerging prior to safe disposal.

The safety mechanism is attached to the body of the needle and iscapable of sliding along the length thereof. In some instances, aninitial or assembled position of the safety mechanism is located inproximity to the base or proximal end of the catheter adapter prior tocatheterization. For some configurations, the assembled position of thesafety mechanism is between the proximal end of the needle hub and theproximal end of the catheter adapter or stabilization platform, whereinthe safety mechanism does not overlap the catheter adapter orstabilization platform. In some instances, a portion of the safetymechanism is positioned within the catheter adapter, with the balance ofthe safety mechanism being positioned external to the catheter adapter,such as within the needle hub. In some embodiments, a portion of thecatheter adapter or stabilization platform is extended proximally toprovide a housing in which at least a portion of the safety mechanism ishoused. In some instances, the entire safety mechanism is housed withinthe housing of the catheter adapter or stabilization platform prior tocatheterization.

In some embodiments, the assembled position of the safety mechanismpositions the proximal end of the catheter adapter between the distalend of the safety mechanism and a distal end of a paddle grip of theneedle hub. In some instances, the assembled position of the safetymechanism positions the proximal end of the catheter adapter between thedistal end of the safety mechanism and a proximal end of a paddle gripof the needle hub. In some instances, a portion of the safety mechanismoverlaps a portion of a paddle grip of the needle hub. In someembodiments, at least some portion of at least one of the catheteradapter and the paddle grip overlaps at least some portion of the safetymechanism. In some embodiments, no portion of the catheter adapter orpaddle grip overlaps any portion of the safety mechanism.

In some embodiments, a defeatable mechanical connection is providedbetween the safety mechanism and at least one other component of theaccess device. In some embodiments, a distal end of the safety mechanismis selectively coupled to a proximal end of the catheter adapter. In oneembodiment, the safety mechanism interlocks internally to the proximalend of the catheter adapter. In one embodiment, the safety mechanisminterlocks externally to the proximal end of the catheter adapter. Insome embodiments, a distal end of the safety mechanism is selectivelycoupled to a proximal end of the stabilization platform. In someembodiments, a surface of the safety mechanism is selectively coupled toat least one surface of at least one of the catheter adapter, a bloodcontrol valve, an extension tube, and the stabilization platform. Insome instances, the mechanical connection is defeated upon securement ofthe needle tip within the safety mechanism.

In some embodiments, a particular catheter device, such as, for example,the catheter device of any of the FIGS. 1-30, may include a needlesafety mechanism. The safety mechanism may include any safety mechanismconfigured to secure a sharpened, distal tip of an introducer needlewhen the needle is withdrawn from a catheter of the particular catheterdevice, preventing accidental needle sticks.

The safety mechanism may be coupled with the particular catheter devicein any number of ways. In some embodiments, the safety mechanism mayinclude an internal interlock in which the safety mechanism is coupledwith an internal surface of a catheter adapter. Coupling may includethreading, fitting, snapping, connecting, attaching, fastening,clipping, hooking, or any other suitable means of coupling. Non-limitingexamples of safety mechanisms that include an internal interlock areprovided in: U.S. Pat. No. 8,496,623, titled BI-DIRECTIONAL CANNULAFEATURE CAPTURE MECHANISM, filed Mar. 2, 2009; U.S. Pat. No. 9,399,120,titled BI-DIRECTIONAL CANNULA FEATURE CAPTURE MECHANISM, filed Jul. 11,2013; U.S. Patent Application No. 62/314,262, titled CANNULA CAPTUREMECHANISM, filed Mar. 28, 2016, each of which is herein incorporated byreference in its entirety. In some embodiments, the safety mechanism mayinclude a clip disposed within the catheter adapter, a non-limitingexample of which is provided in U.S. Pat. No. 6,117,108, titled SPRINGCLIP SAFETY IV CATHETER, filed Jun. 12, 1998, which is hereinincorporated by reference in its entirety.

In some embodiments, the safety mechanism may include an externalinterlock in which the safety mechanism is coupled with an externalsurface of the catheter adapter. In some embodiments, the safetymechanism may be coupled with an external surface of the catheteradapter and an internal and/or external surface of a needle hub.Coupling may include threading, fitting, snapping, connecting,attaching, fastening, clipping, hooking, or any other suitable means ofcoupling. Non-limiting examples of safety mechanisms that include anexternal interlock are provided in U.S. patent application Ser. No.14/295,953, titled PORTED IV CATHETER HAVING EXTERNAL NEEDLE SHIELD ANDINTERNAL BLOOD CONTROL SEPTUM, filed Jun. 4, 2014, which is hereinincorporated by reference in its entirety. In some embodiments, thesafety mechanism may include a V-clip or a similar clip. A non-limitingexample of a V-clip is provided in U.S. patent application Ser. No.14/295,953, titled PORTED IV CATHETER HAVING EXTERNAL NEEDLE SHIELD ANDINTERNAL BLOOD CONTROL SEPTUM, filed Jun. 4, 2014, which is hereinincorporated by reference in its entirety. The V-clip may selectivelyretain a portion of the catheter adapter.

In some embodiments, a defeatable mechanical connection is providedbetween the safety mechanism and at least one other component of the IVcatheter system. In some instances, the mechanical connection isdefeated upon securement of the distal tip of the needle within thesafety mechanism. In some embodiments, a surface of the safety mechanismis selectively coupled to one or more of the following: the catheteradapter, a blood control valve, an extension tube, and one or morepaddle grips.

In some embodiments, the safety mechanism may include a safety barrel,which may be spring-loaded. For example, the safety barrel may be springloaded as in the BD™ Insyte® Autoguard™ BC shielded protective IVcatheter. In some embodiments, the safety mechanism may be passivelyand/or actively activated. In some embodiments, the safety mechanism maybe configured to interact with a needle feature, such as a ferrule,notch, crimp or bump on the needle. In some embodiments, the safetymechanism may include an arm or lever that may be actuated to capturethe distal tip within the safety mechanism and prevent the tip fromemerging prior to safe disposal. In some embodiments, the safetymechanism may be attached to a body of the needle and may be capable ofsliding along the length thereof.

In some embodiments, in an assembled position prior to catheterization,the safety mechanism may be disposed between the catheter adapter andthe needle hub. In some embodiments, the catheter adapter and the needlehub may be spaced apart by at least a portion of the safety mechanism inthe assembled position prior to catheterization. In some embodiments, inthe assembled position prior to catheterization, a proximal end of thecatheter adapter may be disposed between a distal end of the safetymechanism and a distal end of a grip of the needle hub, such as, forexample, a paddle grip. In some embodiments, in the assembled positionprior to catheterization, the proximal end of the catheter adapter bodymay be disposed between the distal end of the safety mechanism and aproximal end of the grip of the needle hub. In some embodiments, aportion of the safety mechanism may overlap with a portion of the gripof the needle hub. In some embodiments, at least a portion of at leastone of the catheter adapter and the grip overlaps at least some portionof the safety mechanism. In some embodiments, no portion of the catheteradapter body or the grip overlaps any portion of the safety mechanism.

In any of the above described embodiments of IV catheter systems thatinclude a catheter component with one or more wings, a wing may beformed in such a manner that it may pivot about an axis defined alongthe longitudinal length of the catheter component. For example, withreference to FIG. 14A, second wing 1442 may be formed of a flexiblematerial and/or may be configured with a hinge (e.g., by forming thewing with a thinned portion along the length of the catheter hub) whichallows the wing to pivot upwardly and downwardly about the longitudinalaxis. One benefit of this type of pivoting is that it allows second wing1442 to be angled upwardly away from the patient's skin duringinsertion. This upward angling would accommodate the clinician's fingeror thumb underneath second wing 1442 thereby facilitating a shallowerangle of insertion. The flexible and/or pivotable wing could then bemoved downward into a flat position for securement to the patient'sskin. U.S. Provisional Patent Application No. 62/247,621, which wasfiled on Oct. 28, 2015 and is incorporated herein by reference,discloses a number of techniques for allowing a wing to be pivoted at anangle which would be suitable for use with many of the above-describedembodiments of IV catheter systems.

In any of the above described embodiments, the components of thesecurement platform may be formed of the same material by injectionmolding or other processes. This material may be an elastomeric or otherlow-durometer material that is relatively gentle against the patient'sskin and/or dressings used to keep the catheter component in placeduring fluid delivery. For example, some embodiments of the presentinvention comprise a low-durometer material having a durometer hardnessof from approximately 30 Shore A to approximately 90 Shore D. In someembodiments, a low-durometer material comprises a durometer hardness offrom approximately 50 Shore A to approximately 90 Shore D. In someembodiments, the components of the securement platform may be formed ofa thermoplastic elastomer (TPE) or the like.

Also, in any of the above described embodiments, the grip and/or otherelements of the needle component may be formed of a clear or whitematerial while some or all of the components of the securement platformmay be formed with a color (e.g., green, pink, blue, yellow, purple,etc.) that is specific to the gauge of the catheter. The color contrastmay facilitate identification by the clinician of parts of the cathetersystem that separate from one another during insertion of the cathetersystem into the vein of the patient, including, for example, hooding ofthe catheter.

The present invention may be embodied in other specific forms withoutdeparting from its structures, methods, or other essentialcharacteristics as broadly described herein and claimed hereinafter. Thedescribed embodiments are to be considered in all respects only asillustrative, and not restrictive. The scope of the invention is,therefore, indicated by the appended claims, rather than by theforegoing description. All changes that come within the meaning andrange of equivalency of the claims are to be embraced within theirscope.

We claim:
 1. An IV catheter system comprising an insertion configurationand a fluid delivery configuration, the IV catheter system comprising: acatheter component comprising: a catheter hub comprising a catheter hubdistal end and a catheter hub proximal end, wherein the catheter hub isshaped to define a chamber extending between the catheter hub distal endand the catheter hub proximal end, and a needle port at the catheter hubproximal end that provides access to the chamber; a cannula extendingdistally from the catheter hub distal end; and a push feature protrudingoutwardly from the catheter hub; and a needle component comprising: aneedle hub comprising a needle hub distal end and a needle hub proximalend; a needle extending distally from the needle hub distal end along anaxis; and a grip extending from the needle hub, generally parallel tothe axis, the grip comprising a pull feature; wherein, in the insertionconfiguration, the needle is positioned within the cannula and theneedle hub distal end is seated in the needle port; wherein, in thefluid delivery configuration, the needle is positioned outside thecatheter hub; wherein the push feature is positioned to receive firstcontact from a first digit of a hand of a user to urge the catheter hubdistally and the pull feature is positioned to receive second contactfrom a second digit of the hand simultaneously with receipt of the firstcontact such that the first and second contacts cooperate to urge the IVcatheter system to move from the insertion configuration to the fluiddelivery configuration.
 2. The IV catheter system of claim 1, whereinthe catheter hub comprises a catheter hub intermediate portion betweenthe catheter hub proximal end and the catheter hub distal end; whereinthe catheter component further comprises an extension tubing junctionextending outwardly from the catheter hub intermediate portion toconnect the catheter hub to extension tubing; and wherein the first wingextends between the catheter hub intermediate portion and the extensiontubing junction but does not extend outwardly beyond the extensiontubing junction.
 3. The IV catheter system of claim 1, wherein theneedle component includes a flash component having a proximal vent andat least one side vent.
 4. The IV catheter system of claim 1, whereinthe catheter component includes a visual indicator.
 5. The IV cathetersystem of claim 4, wherein the visual indicator is covered by the needlehub distal end when a tip of the needle extends distally beyond thecannula and that is exposed when the tip of the needle is withdrawn intothe cannula.
 6. The IV catheter system of claim 1, wherein the needlecomponent includes side grips and the catheter component includes a pushtab.
 7. The IV catheter system of claim 6, wherein the needle componentincludes a flash chamber, the side grips being formed on the flashchamber.
 8. The IV catheter system of claim 1, wherein the cathetercomponent further comprises: a securement platform comprising a firstwing extending from the catheter hub, generally parallel to the axissuch that, in the fluid delivery configuration, the first wing rests onskin of a patient receiving fluid through the IV catheter system; and anextension tubing junction extending outwardly from the catheter hubintermediate portion to connect the catheter hub to extension tubing;wherein the extension tubing junction extends in an opposite directionof the first wing.
 9. The IV catheter system of claim 6, wherein thecatheter component further comprises a second wing that extends in theopposite direction of the first wing, the second wing incorporating butnot extending beyond the extension tubing junction.
 10. The IV cathetersystem of claim 9, wherein the second wing is formed of a rigid materialand the first wing is formed of a flexible material.
 11. The IV cathetersystem of claim 8, wherein the first wing is configured to pivot withrespect to the catheter hub about the axis.
 12. The IV catheter systemof claim 11, wherein the first wing includes a hinge that enables thepivoting.
 13. The IV catheter system of claim 11, wherein the first wingis formed of a flexible material that enables the pivoting.
 14. An IVcatheter system comprising: a catheter component comprising: a catheterhub comprising a catheter hub distal end and a catheter hub proximalend, wherein the catheter hub is shaped to define a chamber extendingbetween the catheter hub distal end and the catheter hub proximal end,and a needle port at the catheter hub proximal end that provides accessto the chamber; a cannula extending distally from the catheter hubdistal end; and a push tab positioned at the catheter hub proximal end;and a needle component comprising: a needle hub comprising a needle hubdistal end and a needle hub proximal end, the needle hub distal endincluding a cut-out that aligns with the push tab formed at the catheterhub proximal end; and a needle extending distally from the needle hubdistal end along an axis.
 15. The IV catheter system of claim 14,wherein the catheter component includes a securement platform.
 16. TheIV catheter system of claim 15, wherein the push tab and the securementplatform are connected via one or more connecting channels.
 17. The IVcatheter system of claim 15, wherein the catheter component includes astrain relief positioned at the catheter hub distal end around thecannula, the strain relief being coupled to the securement platform by aconnecting channel.
 18. The IV catheter system of claim 15, wherein thecatheter component and the needle component each include a protrusionwhich interface to limit rotation of the needle component relative tothe catheter component.
 19. The IV catheter system of 18, wherein theneedle component includes a wing and wherein the protrusions prevent thewing from rotating downward below the securement platform.
 20. The IVcatheter system of claim 14, further comprising; a flash component thatincludes a path-defining structure for controlling flow of blood withinthe flash component.